- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669874
Endoscopic Fundoplication With MUSE System
Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients
This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:
Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:
- effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores
- effect on the use and dosage of proton pump inhibitors (PPI)
- feasibility and safety of the endoluminal fundoplication procedure
- Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.
The study design includes the following phases:
*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
- 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
- 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
- Yearly clinical follow-up (up to 6 years):
PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pier Alberto Testoni, Professor
- Phone Number: +390226432756
- Email: testoni.pieralberto@hsr.it
Study Locations
-
-
-
Milan, Italy, 20132
- Recruiting
- Pier Alberto Testoni
-
Contact:
- Pier Alberto Testoni, MD
- Phone Number: 00390226432756
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
- Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
- Indication to surgical fundoplication
- Patients available for a long-term follow-up
Exclusion Criteria:
- Hiatal hernia ≥ 3 cm
- Major esophageal motility disorder
- Esophageal stenosis
- Malignant neoplasia (except minor superficial skin neoplasm)
- Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
- Previous cardiac, thoracic or upper GI surgery
- BMI >40
- Pregnancy or breast feeding
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time Frame: change from baseline GERD-HRQL at 6 months
|
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms.
The scale range is (0-50); the higher values represents worse outcomes.
|
change from baseline GERD-HRQL at 6 months
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time Frame: change from baseline GERD-HRQL at 12 months
|
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms.
The scale range is (0-50); the higher values represents worse outcomes.
|
change from baseline GERD-HRQL at 12 months
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time Frame: change from baseline GERD-HRQL at 24 months
|
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms.
The scale range is (0-50); the higher values represents worse outcomes.
|
change from baseline GERD-HRQL at 24 months
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time Frame: change from baseline GERD-HRQL at 3 years
|
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms.
The scale range is (0-50); the higher values represents worse outcomes.
|
change from baseline GERD-HRQL at 3 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time Frame: change from baseline GERD-HRQL at 4 years
|
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms.
The scale range is (0-50); the higher values represents worse outcomes.
|
change from baseline GERD-HRQL at 4 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time Frame: change from baseline GERD-HRQL at 5 years
|
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms.
The scale range is (0-50); the higher values represents worse outcomes.
|
change from baseline GERD-HRQL at 5 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
Time Frame: change from baseline GERD-HRQL at 6 years
|
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms.
The scale range is (0-50); the higher values represents worse outcomes.
|
change from baseline GERD-HRQL at 6 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time Frame: change from baseline RSI at 6 months
|
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms.
The scale range is (0-45); the higher values represents worse outcomes.
|
change from baseline RSI at 6 months
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time Frame: change from baseline RSI at 12 months
|
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms.
The scale range is (0-45); the higher values represents worse outcomes.
|
change from baseline RSI at 12 months
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time Frame: change from baseline RSI at 24 months
|
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms.
The scale range is (0-45); the higher values represents worse outcomes.
|
change from baseline RSI at 24 months
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time Frame: change from baseline RSI at 3 years
|
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms.
The scale range is (0-45); the higher values represents worse outcomes.
|
change from baseline RSI at 3 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time Frame: change from baseline RSI at 4 years
|
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms.
The scale range is (0-45); the higher values represents worse outcomes.
|
change from baseline RSI at 4 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time Frame: change from baseline RSI at 5 years
|
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms.
The scale range is (0-45); the higher values represents worse outcomes.
|
change from baseline RSI at 5 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
Time Frame: change from baseline RSI at 6 years
|
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms.
The scale range is (0-45); the higher values represents worse outcomes.
|
change from baseline RSI at 6 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time Frame: change from baseline PPI consumption at 6 months
|
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD.
This therapy is a chronic therapy with possible side effects.
The endoscopic procedure under study aims to halved or discontinue the medical therapy
|
change from baseline PPI consumption at 6 months
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time Frame: change from baseline PPI consumption at 12 months
|
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD.
This therapy is a chronic therapy with possible side effects.
The endoscopic procedure under study aims to halved or discontinue the medical therapy
|
change from baseline PPI consumption at 12 months
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time Frame: change from baseline PPI consumption at 24 months
|
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD.
This therapy is a chronic therapy with possible side effects.
The endoscopic procedure under study aims to halved or discontinue the medical therapy
|
change from baseline PPI consumption at 24 months
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time Frame: change from baseline PPI consumption at 3 years
|
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD.
This therapy is a chronic therapy with possible side effects.
The endoscopic procedure under study aims to halved or discontinue the medical therapy
|
change from baseline PPI consumption at 3 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time Frame: change from baseline PPI consumption at 4 years
|
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD.
This therapy is a chronic therapy with possible side effects.
The endoscopic procedure under study aims to halved or discontinue the medical therapy
|
change from baseline PPI consumption at 4 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time Frame: change from baseline PPI consumption at 5 years
|
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD.
This therapy is a chronic therapy with possible side effects.
The endoscopic procedure under study aims to halved or discontinue the medical therapy
|
change from baseline PPI consumption at 5 years
|
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
Time Frame: change from baseline PPI consumption at 6 years
|
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD.
This therapy is a chronic therapy with possible side effects.
The endoscopic procedure under study aims to halved or discontinue the medical therapy
|
change from baseline PPI consumption at 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size
Time Frame: change from baseline hiatal hernia size at 6 months
|
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus.
The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
|
change from baseline hiatal hernia size at 6 months
|
To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size
Time Frame: change from baseline hiatal hernia size at 12 months
|
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus.
The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
|
change from baseline hiatal hernia size at 12 months
|
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade
Time Frame: change from baseline Hill's grade at 6 months
|
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus.
The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve.
The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
|
change from baseline Hill's grade at 6 months
|
To identify endoscopic factors predicting positive outcomes: changes in Hill's grade
Time Frame: change from baseline Hill's grade at 12 months
|
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus.
The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve.
The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
|
change from baseline Hill's grade at 12 months
|
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght
Time Frame: change from baseline Jobe's lenght at 6 months
|
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus.
The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
|
change from baseline Jobe's lenght at 6 months
|
To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght
Time Frame: change from baseline Jobe's lenght at 12 months
|
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus.
The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
|
change from baseline Jobe's lenght at 12 months
|
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade
Time Frame: change from baseline esophagitis' grade at 6 months
|
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus.
The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy.
The esophagitis grade range from A to D; the higher grades represents worse outcomes.
|
change from baseline esophagitis' grade at 6 months
|
To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade
Time Frame: change from baseline esophagitis' grade at 12 months
|
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus.
The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy.
The esophagitis grade range from A to D; the higher grades represents worse outcomes.
|
change from baseline esophagitis' grade at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score
Time Frame: change from baseline DeMeester score at 6 months
|
parameter detected by 24hours esophagel pH-metry.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position).
A score of >14.72 shows a pathological reflux.
Higher values represent worse outcomes.
|
change from baseline DeMeester score at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score
Time Frame: change from baseline DeMeester score at 12 months
|
parameter detected by 24hours esophagel pH-metry.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position).
A score of >14.72 shows a pathological reflux.
Higher values represent worse outcomes.
|
change from baseline DeMeester score at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)
Time Frame: change from baseline AET at 6 months
|
parameter detected by 24hours esophagel pH-metry.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline AET at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)
Time Frame: change from baseline AET at 12 months
|
parameter detected by 24hours esophagel pH-metry.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline AET at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)
Time Frame: change from baseline longest reflux episode at 6 months
|
parameter detected by 24hours esophagel pH-metry.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline longest reflux episode at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)
Time Frame: change from baseline longest reflux episode at 12 months
|
parameter detected by 24hours esophagel pH-metry.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline longest reflux episode at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes
Time Frame: change from baseline number of refluxes greater than 5 minutes at 6 months
|
parameter detected by 24hours esophagel pH-metry.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of refluxes greater than 5 minutes at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes
Time Frame: change from baseline number of refluxes greater than 5 minutes at 12 months
|
parameter detected by 24hours esophagel pH-metry.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of refluxes greater than 5 minutes at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes
Time Frame: change from baseline number of total refluxes at 6 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of total refluxes at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes
Time Frame: change from baseline number of total refluxes at 12 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of total refluxes at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes
Time Frame: change from baseline number of acid refluxes at 6 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of acid refluxes at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes
Time Frame: change from baseline number of acid refluxes at 12 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of acid refluxes at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes
Time Frame: change from baseline number of weakly acid refluxes at 6 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of weakly acid refluxes at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes
Time Frame: change from baseline number of weakly acid refluxes at 12 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of weakly acid refluxes at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes
Time Frame: change from baseline number of not acid refluxes at 6 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of not acid refluxes at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes
Time Frame: change from baseline number of not acid refluxes at 12 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of not acid refluxes at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes
Time Frame: change from baseline number of proximal refluxes at 6 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of proximal refluxes at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes
Time Frame: change from baseline number of proximal refluxes at 12 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline number of proximal refluxes at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)
Time Frame: change from baseline MNBI at 6 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline MNBI at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)
Time Frame: change from baseline MNBI at 12 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline MNBI at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)
Time Frame: change from baseline PSPW at 6 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline PSPW at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)
Time Frame: change from baseline PSPW at 12 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline PSPW at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)
Time Frame: change from baseline BCT at 6 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline BCT at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)
Time Frame: change from baseline BCT at 12 months
|
parameter detected by 24hours esophagel impedance.
pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
|
change from baseline BCT at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure
Time Frame: change from baseline LES basal pressure at 6 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline LES basal pressure at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure
Time Frame: change from baseline LES basal pressure at 12 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline LES basal pressure at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght
Time Frame: change from baseline LES lenght at 6 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline LES lenght at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght
Time Frame: change from baseline LES lenght at 12 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline LES lenght at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)
Time Frame: change from baseline LES IRP at 6 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline LES IRP at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)
Time Frame: change from baseline LES IRP at 12 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline LES IRP at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)
Time Frame: change from baseline DCI at 6 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline DCI at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)
Time Frame: change from baseline DCI at 12 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline DCI at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves
Time Frame: change from baseline rate of peristaltic waves at 6 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline rate of peristaltic waves at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves
Time Frame: change from baseline rate of peristaltic waves at 12 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline rate of peristaltic waves at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves
Time Frame: change from baseline rate of weak waves at 6 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline rate of weak waves at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves
Time Frame: change from baseline rate of weak waves at 12 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline rate of weak waves at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves
Time Frame: change from baseline rate of fragmented waves at 6 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline rate of fragmented waves at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves
Time Frame: change from baseline rate of fragmented waves at 12 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline rate of fragmented waves at 12 months
|
To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves
Time Frame: change from baseline rate of failed waves at 6 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline rate of failed waves at 6 months
|
To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves
Time Frame: change from baseline rate of failed waves at 12 months
|
parameter detected by High Resolution Esophageal Manometry (HRM).
The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
|
change from baseline rate of failed waves at 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pier Alberto Testoni, Professor, San Raffaele Scientific Institute
Publications and helpful links
General Publications
- Testoni SGG, Cilona MB, Mazzoleni G, Fanti L, Ribichini E, Cavestro GM, Esposito D, Viale E, Notaristefano C, Zuppardo RA, Azzolini F, Passaretti S, Testoni PA. Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years. Surg Endosc. 2022 Jul;36(7):5023-5031. doi: 10.1007/s00464-021-08860-w. Epub 2021 Nov 19.
- Testoni PA, Testoni S, Mazzoleni G, Pantaleo G, Cilona MB, Distefano G, Fanti L, Antonelli M, Passaretti S. Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes. Endoscopy. 2020 Jun;52(6):469-473. doi: 10.1055/a-1124-3187. Epub 2020 Mar 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUSE/2015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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