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NCT03322553

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

Completed NA Last updated 22 January 2020
What this trial tests

NA trial testing GERD-X in Gastro Esophageal Reflux Disease in 70 participants. Completed in 30 December 2019.

Timeline
15 November 2017
Primary endpoint
30 August 2019
30 December 2019

Quick facts

Lead sponsorAsian Institute of Gastroenterology, India
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment70
Start date15 November 2017
Primary completion30 August 2019
Estimated completion30 December 2019
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Asian Institute of Gastroenterology, India

Who can join

Adults 18 to 60, any sex, with Gastro Esophageal Reflux Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial.
    Kalapala R, Karyampudi A, Nabi Z, Darisetty S, et al · · 2022 · cited 39× · PMID 33849942 · DOI 10.1136/gutjnl-2020-321811
  2. Systematic mapping of registered interventional studies addressing the top 10 research priorities in Barrett's oesophagus and gastro-oesophageal reflux disease.
    Gamakaranage C, Ratcliffe E, Britton J, Butler T, et al · · 2025 · PMID 40527525 · DOI 10.1136/bmjgast-2025-001738

Verify or expand the search:

Other recruiting trials for Gastro Esophageal Reflux Disease

Currently open trials in the same condition.

Other Asian Institute of Gastroenterology, India trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03322553.

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