the Efficency and Safety of Stretta in GERD

the Efficency and Safety of the Endoscopic Radiofrequency Procedure in Gastroesophageal Reflux Diseases

This study evaluated the efficency and safety of the endoscopic radiofrequency procedure(Stretta) in adult gastroesophageal patients.

Study Overview

• Status: Unknown
• Conditions: GERD; Radiofrequency Ablation
• Intervention / Treatment: Device: Stretta

Detailed Description

Gastro-esophageal reflux disease (GERD) is the most common outpatient diagnosis in gastroenterology and is associated with a significant burden on the healthcare system. Proton pump inhibitors (PPIs) are the mainstay of GERD treatment,howerver, some patients have an unsatisfactory response to high doses of PPIs, which remains a challenge. The Stretta procedure, a radiofrequency (RF) application to the lower esophageal sphincter (LES), was introduced about 15 years ago as an alternative to chronic medical therapy or surgical intervention for GERD.The Stretta procedure appears to result in thickening of the LES, decreased transient LES relaxation rate and reduced esophageal acid exposure.The majority studies of Stretta were held in USA and Europe, the sduty of Stretta in Asia is rare. The investigators propose to perform a prospectively observiton study to evaluate the efficency of the Stretta procedure in patients of refractory GERD in China.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Hao Zi Guo, MD; Phone Number: 86+15801227696; Email: zihaoguo@139.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Gastroenterology department,Beijing Tong Ren Hospital, Capital Medical University.
      • Contact: Hao Zi Guo, MD; Phone Number: 86+15801227696; Email: zihaoguo@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with refractory GERD symptoms, without major esophagus motility disorder and large hiatus hernia.

Description

Inclusion Criteria:

1. Age > 18 years
2. Small hiatus hernia (< 2-3 cm)
3. Los Angeles Grade 'A' or 'B' Reflux Esophagitis or non erosive esophagitis
4. LES pressure <15 mm Hg
5. PPI dependent / refractory GERD
6. abnormal 24h esophagus pH-impedance monitoring

Exclusion Criteria:

1. Age < 18 years
2. Large hiatus hernia (> 3 cm)
3. Los Angeles Grade 'C' or 'D' Reflux Esophagitis
4. LES pressure > 15 mm Hg
5. Underlying coagulation disorder
6. Previous Esophageal or Gastric surgery
7. Pregnant
8. major esophagus motility disorder according to Chicago v3.0

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stretta; Radio Frequency Ablation (RFA) using a Stretta device.	Device: Stretta; Stretta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GERD-HRQL scores	the improvement of GERD-HRQL scores after procedure.Scale ranges 0-50 points, the lower score means the better efficacy.	[Time Frame: Change from Baseline HRQL scores at 1 month;Change from Baseline HRQL scores at 2 months;Change from Baseline HRQL scores at 6 months;Change from Baseline HRQL scores at 1 year]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who report independence from Proton Pump Inhibitor (PPI) drug post Stretta procedure	Questionnaire will be provided to each participant to report no further requirement of PPI drug post procedure.	Change from Baseline number at 1 month;Change from Baseline number at 2 months;Change from Baseline number at 6 months;Change from Baseline number at 1 year]
Demeester Score	the change of Demeester scores after procedure. The lower, the better.	1 year
LES Pressure	the change of LES pressure after procedure.The higher, the better.	1 year
Number of participants with treatment-related adverse events	Number of participants with treatment-related adverse events	1 month

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Study Chair: Chuan Zhang, MD, Gatroenterology department,Beijing Tong Ren Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: safety; GERD; Radiofrequency ablation; efficiency
• Other Study ID Numbers: xhnk001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No