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New study pits two Weight-Loss surgeries Head-to-Head

NCT ID NCT02139813

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two types of weight-loss surgery in 256 adults with severe obesity. The goal was to see if a newer, simpler surgery (Omega Loop bypass) works as well as the standard Roux-en-Y gastric bypass, with fewer side effects. Participants were followed for two years to measure weight loss, complications, and quality of life.

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

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

256 people

The number who actually took part.

Started

May 2014

Finished

Mar 2018

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged between 18 and 65 years old * Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis) * Patient who has benefited from an upper GI endoscopy with biopsies * Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for a gastric bypass * Patient who understands and accepts the need for a long term follow-up * Patient who agrees to be included in the study and who signs the informed consent form * Patient affiliated to a healthcare insurance plan Exclusion Criteria: * History of esophagitis on upper GI endoscopy (Los Angeles classification) * Severe gastroesophageal reflux disease (GERD), resistant to medical treatment * Presence of dysplastic modifications of the gastric mucosa or a history of gastric cancer, on upper gastrointestinal endoscopy. * Presence of Helicobacter Pylori resistant to medical treatment * Presence of an unhealed gastro-duodenal ulcer or an ulcer diagnosed less than 2 months previously * History of previous bariatric surgery (gastric band, sleeve gastrectomy, vertical banded gastroplasty) * Presence of a severe and evolutive life threatening pathology, unrelated to obesity * Presence of chronic diarrhea (≥ 3 loose or liquid stools per day, over a period of more than 4 weeks) * Pregnancy or desire to be pregnant during the study * Binge eating disorders or other eating disorders according to DSM V criteria * Mentally unbalanced patients, under supervision or guardianship * Patient who does not understand French/is unable to give consent * Patient not affiliated to a French or European healthcare insurance * Patient who has already been included in a trial which has a conflict of interests with the present study

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Conditions

The condition(s) this trial relates to.

morbid obesity Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche

    Guilherand-Granges, 07500, France

  • Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble

    Grenoble, 38043, France

  • Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon

    Lyon, 69437, France

  • Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire

    Saint-Grégoire, 35768, France

  • Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière

    Paris, 75013, France

  • Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP

    Paris, 75908, France

  • Service de Chirurgie Générale - Hôpital Privé de la Loire

    Saint-Etienne, 42100, France

  • Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille

    Lille, 59037, France

  • Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye

    Saint-Germain-en-Laye, 78100, France

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Other studies related to the condition(s) this trial covers.