Bypass, GastricFEE-RGOICNCT06621979
Evaluation of the Fundoplicature of the Excluded Stomach Post Omega Bypass
A study testing Bypass surgery type one anastomosis gastric bypass in people with Bypass, Gastric, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bypass, Gastric
- What is being tested?
- Bypass surgery type one anastomosis gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique des Cèdres
Cornebarrieu, 31700
Arnaud LIAGRE, MD, + 33 (0)5 62 13 27 58, arnaud.liagre@orange.fr
About this study
Official title: Evaluation of Post-Omega Bypass Excluded Stomach Fundoplication to Treat Disabling Gastroesophageal Reflux Disease Resistant to Medical Treatment and Requiring Surgery
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.
Read the detailed description
The FEE\& RGOIC trial is a single-center, ambispective, interventional, non-randomized pilot study to evaluate the efficacy of Fundoplicature with stomach excluded objectively and comprehensively in the treatment of disabling gastroesophageal reflux requiring gastric bypass after anastomosis.
The strategy under study is objective reflux suppression after fundoplication with the stomach excluded in the following specific context: treatment of disabling gastroesophageal reflux requiring post-bypass surgery in Omega.
The eligible study population will be any adult patient at the investigating center who has undergone one-anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach as part of treatment for disabling post-bypass gastro-oesophageal reflux, resistant to medical treatment and requiring surgery.
- Conditions
- Bypass, Gastric
- Being tested
- Bypass surgery type one anastomosis gastric bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bypass surgery type one anastomosis gastric bypassProcedure or surgery
Adult patients who have undergone single-anastomosis gastric bypass followed by fundoplication of the excluded stomach for the treatment of disabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Gastroesophageal reflux disease | Experimental | Disabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgery Receives: Procedure: Bypass surgery type one anastomosis gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate after Fundoplicature with stomach excluded
The primary endpoint is the long-term efficacy of Fundoplicature with stomach excluded in the treatment of disabling Gastroesophageal Reflux Disease requiring Omega post-bypass surgery after surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start24 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bypass, GastricStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study that aims to objectively assess the resolution of gastroesophageal reflux following fundoplication with gastric exclusion in the following specific context: the treatment of debilitating gastroesophageal reflux requiring post-Omega bypass surgery. This is not a comparative study of treatment arms. However, the study aims to compare data from pre- and post-operative examinations in order to observe the effect of the procedure on the objective assessment of gastroesophageal reflux symptoms.
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621979
- Sponsor's protocol ID
- 2023-A02501-44
- Acronym
- FEE-RGOIC
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-Omega Bypass Excluded Stomach Fundoplication to Treat Disabling Gastroesophageal Reflux Disease Resistant to Medical Treatment and Requiring Surgery
- ClinicalTrials.gov ID
- NCT06621979
- Acronym / sponsor ID
- FEE-RGOIC / 2023-A02501-44
- Conditions
- Bypass, Gastric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The FEE\& RGOIC trial is a single-center, ambispective, interventional, non-randomized pilot study to evaluate the efficacy of Fundoplicature with stomach excluded objectively and comprehensively in the treatment of disabling gastroesophageal reflux requiring gastric bypass after anastomosis.
The strategy under study is objective reflux suppression after fundoplication with the stomach excluded in the following specific context: treatment of disabling gastroesophageal reflux requiring post-bypass surgery in Omega.
The eligible study population will be any adult patient at the investigating center who has undergone one-anastomosis gastric bypass surgery followed by fundoplication of the excluded stomach as part of treatment for disabling post-bypass gastro-oesophageal reflux, resistant to medical treatment and requiring surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study that aims to objectively assess the resolution of gastroesophageal reflux following fundoplication with gastric exclusion in the following specific context: the treatment of debilitating gastroesophageal reflux requiring post-Omega bypass surgery. This is not a comparative study of treatment arms. However, the study aims to compare data from pre- and post-operative examinations in order to observe the effect of the procedure on the objective assessment of gastroesophageal reflux symptoms.
| Arm | Type | Receives |
|---|---|---|
| Gastroesophageal reflux disease | Experimental | Procedure: Bypass surgery type one anastomosis gastric bypassDisabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bypass surgery type one anastomosis gastric bypassAdult patients who have undergone single-anastomosis gastric bypass followed by fundoplication of the excluded stomach for the treatment of disabling post-bypass gastroesophageal reflux, resistant to medical treatment and requiring surgical intervention. | Procedure or surgery | Gastroesophageal reflux disease |
Primary outcome
Response rate after Fundoplicature with stomach excluded
Time frame: 2 years
The primary endpoint is the long-term efficacy of Fundoplicature with stomach excluded in the treatment of disabling Gastroesophageal Reflux Disease requiring Omega post-bypass surgery after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bypass surgery type one anastomosis gastric bypass in people with Bypass, Gastric, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud LIAGRE, MD (0562132758 ext. + 33, arnaud.liagre@orange.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate after Fundoplicature with stomach excluded (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.