Actively Recruiting
Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2025-12-03
17
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
Sponsors
G
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead Sponsor
E
Euraxi Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy of fundoplication with stomach excluded in the suppression of disabling gastroesophageal reflux requiring surgery in patients who have undergone one anastomosis gastric bypass, with complete objective evaluation of reflux.
CONDITIONS
Official Title
Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Underwent one-anastomosis gastric bypass followed by fundoplication with the excluded stomach for disabling gastroesophageal reflux requiring surgery within 2 years before joining
- Failed medical treatment for gastroesophageal reflux
- Achieved weight loss greater than 50% of excess weight
- Completed preoperative tests including gastrojejunal fibroscopy, pH-impedancemetry, and abdominal CT scan for reflux disease
- Able to understand study information and complete quality-of-life questionnaires
- Willing to accept study evaluations
- For women of childbearing age, using effective contraception or have a negative pregnancy test
- Provided free, informed, and written consent
You will not qualify if you...
- Converted from one-anastomosis gastric bypass to Y bypass for disabling gastroesophageal reflux
- Underwent hiatal hernia correction along with one-anastomosis gastric bypass
- Had a secondary one-anastomosis gastric bypass
- Following an unregulated diet
- Under legal protection or deprived of liberty by judicial or administrative decision
- Unable to understand study information due to language, psychological, cognitive, or other reasons
- Women who are pregnant, breastfeeding, or of childbearing age without effective contraception
- Participating in another clinical trial or within an exclusion period from another trial that could interfere
- Not covered by a social security scheme
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinique des Cèdres
Cornebarrieu, France, 31700
Actively Recruiting
Research Team
A
Arnaud LIAGRE, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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