NCT06621979 Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass
| NCT ID | NCT06621979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche |
| Condition | Bypass, Gastric |
| Study Type | INTERVENTIONAL |
| Enrollment | 17 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 17 participants in total. It began in 2025-11-24 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Patient operated for one anastomosis gastric bypass followed by Fundoplicature with stomach excluded for disabling gastroesophageal reflux requiring surgery within 2 years prior to inclusion; * Patient in failure of medical treatment; * Weight loss greater than 50% of excess weight; * Patient with preoperative objective investigations (gastrojejunal fibroscopy, ph-impedancemetry, abdominal CT scan) of gastroesophageal reflux disease; * Patient able to understand study-related information and to complete quality-of-life questionnaires in the opinion of the investigator; * Patient willing to accept study evaluations; * For women of childbearing age, effective contraception for the duration of the study or negative blood pregnancy test; * Patient has been informed and has given free, informed and written consent. Exclusion Criteria: * Patient with conversion from one anastomosis gastric bypass to Y bypass for disabling gastroesophageal reflux requiring surgery; * Patient with concomitant hiatal hernia correction for one anastomosis gastric bypass ; * Patient with secondary one anastomosis gastric bypass ; * Patient with a deregulated diet; * Patient under legal protection, or deprived of liberty by judicial or administrative decision; * Patient unable to understand study information for linguistic, psychological, cognitive or other reasons; * Women who are or may become pregnant, of childbearing age, without effective contraception or who are breast-feeding; * Patient participating in another clinical trial, or in a period of exclusion from another clinical trial that could interfere with the results of the present study; * Patient not covered by a social security scheme.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06621979 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bypass, Gastric. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06621979 currently recruiting?
Yes, NCT06621979 is actively recruiting participants. Contact the research team at arnaud.liagre@orange.fr for enrollment information.
Where is the NCT06621979 trial being conducted?
This trial is being conducted at Cornebarrieu, France.
Who is sponsoring the NCT06621979 clinical trial?
NCT06621979 is sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. The trial plans to enroll 17 participants.