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Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD:

NCT03322553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-01-22

No results posted yet for this study

Summary

Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disorder with a significant proportion of patients becoming dependent on proton pump inhibitor (PPI) therapy. Long term use of PPI therapy can be associated with side effects such as osteoporosis, small intestinal bacterial overgrowth and renal failure. Moreover, some of the patients might be reluctant to take PPIs for long duration and prefer surgery over pharmacotherapy. Endoscopic plication (GERD-X) is an alternative and less invasive procedure compared to laparoscopic fundoplication for the treatment of GERD. In endoscopic plication, transmural sutures are applied at the gastro-esophageal (GE) junction thereby reconstructing the gastric cardia and accentuating the valvular mechanism to prevent reflux. Only few trials have evaluated the efficacy of endoscopic plication technique and reported encouraging results. In this study we aim to evaluate the efficacy of a similar endoscopic technique but with application of two transmural sutures in randomized controlled method.

Conditions

  • Gastro Esophageal Reflux Disease

Interventions

DEVICE

GERD-X

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.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Dr. D. Nageshwar Reddy, MBBS · Asian Institute of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2019-08-30
Completion
2019-12-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03322553 on ClinicalTrials.gov