New surgery aims to fix reflux after Weight-Loss bypass
NCT ID NCT06621979
First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study looks at a second surgery for people who had gastric bypass but still suffer from severe acid reflux that medication can't control. The procedure wraps part of the stomach to stop reflux. Researchers will follow 17 adults for up to 2 years to see if the surgery works and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fundoplication surgery on the excluded stomach
- What this could lead to
- If successful, this could offer a reliable surgical fix for severe acid reflux after gastric bypass, reducing the need for long-term medication.
- What could go wrong
- This is a very small study (17 people) with no control group, so results may not apply widely. Surgery carries risks like infection or complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 17 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinique des Cèdres
RECRUITINGCornebarrieu, 31700, France
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