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NCT03322553
Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD:
NA trial testing GERD-X in Gastro Esophageal Reflux Disease in 70 participants. Completed in 30 December 2019.
30 August 2019
Quick facts
| Lead sponsor | Asian Institute of Gastroenterology, India |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 15 November 2017 |
| Primary completion | 30 August 2019 |
| Estimated completion | 30 December 2019 |
| Sites | 1 location across India |
Drugs / interventions tested
- GERD-X
Conditions studied
- Gastro Esophageal Reflux Disease — all drugs for Gastro Esophageal Reflux Disease →
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):
-
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 -
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:
- PubMed search for NCT03322553
- Europe PMC full search
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Currently open trials in the same condition.
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Other Asian Institute of Gastroenterology, India trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03322553 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asian Institute of Gastroenterology, India
- Last refreshed: 22 January 2020
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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