Gastro-oesophageal Reflux Disease Trial, Recruiting NCT04994665 Sponsor: Centre Hospitalier Departemental Vendee Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT04994665
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older.
  • People who are scheduled to have a sleeve gastrectomy (a type of weight-loss stomach surgery) as their first weight-loss operation.
  • People with a Body Mass Index (BMI) of 35–40 who also have at least one serious health condition that surgery is likely to improve, according to French health authority guidelines — OR people with a BMI of 40 or above.
  • People who have already been followed by a medical team for at least 6 months before their planned surgery.
  • People whose surgery has been approved by a multidisciplinary team (a group of different specialists).
  • People who have received a certificate from a psychiatrist confirming there is no reason they should not have the surgery.
  • People who are able to understand the study and have agreed to take part.
  • People who have French social security coverage.

Who may not be able to join:

  • People who have an eating disorder or a mental health condition.
  • People who are unable to understand the study protocol.
  • People for whom a psychiatrist has found a reason the surgery should not go ahead.
  • People with a BMI below 35.
  • People with a BMI between 35 and 40 who do not have any related serious health conditions.
  • People found to have a certain level of oesophagus inflammation (grade B or above on a specific stomach camera test) (confirm with trial site).
  • People with a CARLSSON score of 4 or higher before surgery (confirm with trial site).
  • People currently taking a medication called a Proton-Pump Inhibitor (a type of medication commonly used for heartburn or stomach acid).
  • People who are planned to have a two-stage surgery (sleeve gastrectomy followed later by a gastric bypass or a similar procedure).
  • People already taking part in another clinical trial involving a medication or medical device.
  • People who are pregnant, breastfeeding, or who could become pregnant and are not using effective contraception at the time of joining the trial and for up to 24 months after surgery.
  • People who are under legal guardianship or court-appointed protection.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Emeric Abet, Dr, CHD Vendée

Phone: 251446380

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Centre Hospitalier Departemental Vendee
Registry
ClinicalTrials.gov
Start date
7 December 2021
Est. completion
1 November 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov