- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322553
Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD:
Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD: Randomized, Double Blinded, Sham Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients screening and inclusion:
The study will be conducted over 6-month period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD health related quality of life questionnaire (GERD HRQL) and requirement of anti-secretory medicines (detailed drug history) will be assessed along with gastroscopy. All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs. Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines. Basal lower esophageal sphincter (LES) pressure, esophageal motility pattern, 24-h esophageal acid exposure, non acidic bolus reflux, number of reflux episodes, DeMeester score, symptom index and symptom association probability would be assessed. Those patients with pathologic esophageal acid exposure (esophageal pH <4 for >4.2% of 24-h period) will be included in the trial. Patients will then be randomly assigned by a computer to either GERD-X or sham procedure with a target ratio of 1:1. The patient, principle investigator and the study coordinators would be blinded to the treatment assignment.
Intervention:
In patients allocated to endoscopic plication, endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire and into the stomach. The subsequent procedure will be performed as described in previous studies, using a similar device (NDO Plicator). According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the endoscope. In sham procedure, identical technique will be followed by positioning the plicator 1cm below the GE junction but sutures will not be deployed.
Post intervention monitoring:
Immediately after the intervention, patients would be placed on soft diet and on demand analgesics for 5 days. Twice daily PPI will be given for all patients and would be stopped after 7 days. Thereafter, if patient experiences reflux symptoms, sucralfate, H2 blocker and PPI would be started sequentially in case of no response to the former drug after a period of 7days of therapy on each drug. Requirement and reintroduction of drugs will be enquired over phone and recorded appropriately.
Follow up:
Follow up visits will be carried out at 3, 6 and 12 months. During each visit, gastroscopy will be done to assess the gastro-esophageal junction along with evaluation of GERD HRQL and requirement of PPI. At 3 months post intervention, esophageal manometry and 24-h pH impedance monitoring would be performed.
Primary outcomes:
Improvement in GERD HRQL by more than 50% from baseline at 3 months
Secondary outcomes:
Improvement in GERD HRQL at 3, 6 and 12 months Improvement in symptom score and requirement of PPI at 3, 6 and 12 months Improvement in esophageal acid exposure and lower esophageal sphincter pressure at 3 months
Statistical Analysis The trial was designed to have a 90% power to detect a difference in GERD-HRQL post intervention at 5% level of significance.
The rate of improvement in GERD-HRQL for sham group is 35% and for active group is 70 %. A sample size of 38 is required for each group to achieve a statistical power of 80% at 5% type I error.
Statistical methods Continuous data will be expressed as median and inter-quartile range (IQR). Frequency will be expressed as percentage (%). Continuous and categorical data between active and sham groups will be compared using Mann-Whitney U test and Chi-square test, with Yates' correction as applicable, respectively. P values below 0.05 will be considered significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Telangana
-
Hyderabad, Telangana, India, 500082
- Asian Institute of Gastroenterology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal pH less than 4 of more than 4.2% on pH-metry during 24-h period while off PPI
- Patients who are willing to pay the expenses of the GERD-X procedure
Exclusion Criteria:
- Large Hiatal hernia >3cm
- Gr C/D esophagitis
- Lower esophageal sphincter (LES) pressure <5 or >15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
- Barretts esophagus
- Esophageal dysmotility
- ASA physical status >II
- Previous esophageal or gastric surgery
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plication group
In patients allocated to endoscopic plication, endoscopic full-thickness plication will be performed using the GERDX® system.
All procedures will be performed under general anesthesia.
Savary-guidewire will be placed into the stomach using a gastroscope.
The GERDX® system will be introduced over the guidewire into the stomach and retroflexed.
The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device.
According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the GERD-X device
|
Endoscopic full-thickness plication will be performed using the GERDX® system.
All procedures will be performed under general anesthesia.
Savary-guidewire will be placed into the stomach using a gastroscope.
The GERDX® system will be introduced over the guidewire into the stomach and retroflexed.
The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device.
According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of gastro-esophageal junction around the GERD-X device.
|
Sham Comparator: Sham Group
In sham procedure, identical technique will be followed by positioning the plicator inside the stomach but sutures will not be applied.
|
Endoscopic full-thickness plication will be performed using the GERDX® system.
All procedures will be performed under general anesthesia.
Savary-guidewire will be placed into the stomach using a gastroscope.
The GERDX® system will be introduced over the guidewire into the stomach and retroflexed.
The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device.
According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of gastro-esophageal junction around the GERD-X device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in GERD
Time Frame: 3months
|
Improvement in GERD HRQL by more than 50% from baseline at 3 months GERD - Health Related Quality of Life Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination. |
3months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in GERD overall symptom and quality of life score
Time Frame: 12 months
|
Improvement in GERD HRQL at 3, 6 and 12 months GERD - Health Related Quality of Life Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination. |
12 months
|
Improvement in GERD symptom sub-score
Time Frame: 12 months
|
Improvement in GERD symptom (heartburn and regurgitation) score at 3, 6 and 12 months GERD - Health Related Quality of Life Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores toquestions 1-15 Greatest possible score ( worst symptoms)= 75 Lowest possible score ( no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination. |
12 months
|
Requirement of PPI
Time Frame: 12 months
|
Requirement of PPI for control of symptoms at 3, 6 and 12 months Heartburn and Regurgitation questionnaire 0 =No symptom 1 =Symptoms noticeablebut not bothersome 2=S ymptoms noticeableand bothersome but noteve ry day 3 =Symptoms bothersome every day 4 =Symptoms affect daily activity 5 =Symptoms are incapacitating to do daily activities |
12 months
|
Improvement in oesophageal acidification
Time Frame: 3 months
|
Improvement in oesophageal acid exposure at 3 months pH more than 4 of more than 4.2% |
3 months
|
Improvement in lower oesophageal sphincter pressure
Time Frame: 3 months
|
Improvement in lower oesophageal sphincter pressure at 3 months Lower Esophageal Sphincter pressure > 15 mm Hg |
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Dr. D. Nageshwar Reddy, MBBS, Asian Institute of Gastroenterology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- GERDX01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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