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NCT03999502

Endomina Suturing Device as a Treatment of GERD.

Status unknown NA Last updated 2 March 2021
What this trial tests

NA trial testing Endomina in GERD in 15 participants. Status unknown.

Timeline
15 May 2018
Primary endpoint
12 May 2021
12 May 2022

Quick facts

Lead sponsorErasme University Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date15 May 2018
Primary completion12 May 2021
Estimated completion12 May 2022
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Erasme University Hospital

Who can join

Adults 21 to 70, any sex, with GERD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gastroesophageal Reflux Disease (GERD) is a common problem affecting 10-20% of the population in the Western World. Surgical therapy is able to restore the EGJ barrier function against reflux of the gastric content, decreases symptoms and improves the quality of life in GERD patients. However, there remain concerns regarding postoperative adverse events and the durability of the surgical procedure. The ability to perform endoscopic full-thickness plications with Endomina-v2 will be used to assess safety and feasibility of the procedure in reducing GERD in patients suffering with chronic GERD, unsatisfied with PPIs, and/or complaining of persistent GERD symptoms despite PPI use.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pilot study of an endoluminal-suturing device as a treatment for patients with gastroesophageal reflux disease.
    Louis H, Van Ouytsel P, Leclercq L, Houinsou Hans M, et al · · 2023 · PMID 38026783 · DOI 10.1055/a-2185-5947

Verify or expand the search:

Other trials of Endomina

Trials testing the same drug.

Other recruiting trials for GERD

Currently open trials in the same condition.

Other Erasme University Hospital trials

Trials by the same sponsor.

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Data sources for this page

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