Severe ObesityBIPASSNCT04915014
Sleeve Gastrectomy With Transit Bipartition(SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB) for Type 3 Obesity
A study testing sleeve gastrectomy with transit bipartition (SG +TB) and Roux-en-Y gastric bypass (RYGB) in people with Severe Obesity, run by University Hospital, Lille at 8 sites in France.
Trial summary
Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Obesity
- What is being tested?
- sleeve gastrectomy with transit bipartition (SG +TB) and Roux-en-Y gastric bypass (RYGB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 8 sitesFrance
- Study dates
- 23 Jul 2021to Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SG+TB or RYGB as a first intention procedure with BMI ≥40 kg/m2 or BMI ≥ 35 kg/m2 associated with one co-morbidity which will be improved by surgery (according to HAS 2009 recommendation3) OR as a second intention procedure (revisional surgery) after failure of Sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20%)).
- Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter Pylori (HP) and a HP eradication.
- 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
Who cannot join
- History of previous bariatric surgery, other than a Sleeve Gastrectomy
- Patient with current BMI > 60 kg/m2
- Presence of a severe and evolutive life threatening pathology, unrelated to obesity
- History of Chronic inflammatory bowel disease
- Type 1 Diabetes
- Pregnancy or desire to be pregnant during the study
Show all 16Show fewer
- Nursing woman
- Presence of Pylori Helicobacter resistant to medical treatment
- Presence of a non-healed gastro-duodenal ulcer or diagnosed less than 2 months previously
- Severe esophagitis (grade C of Los Angeles classification)
- Hiatal hernia
- Patients with unstable psychiatric disorder, 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
- Patient incarcerated
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hop Claude Huriez Chu Lille
Lille, 59037
CHU de Lyon
Lyon
CHU de Nantes
Nantes
CHU Orléans
Orléans
AP-HP Hôpital Bichat
Paris
AP-HP Hôpital Georges Pompidou
Paris
CHU de Poitiers
Poitiers
CHU de Nancy
Vandœuvre-lès-Nancy
About this study
Official title: Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Sleeve Gastrectomy With Transit Bipartition (SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB)
Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. Sleeve Gastrectomy (SG) has become the most performed intervention either worldwide or in France, where SG represents more than 60% of bariatric interventions and 114,817 patients operated between 2013 and 2016.
Maximum Excess weight loss (%EWL) after SG is obtained at one-year post surgery. Then it has been largely reported in the literature that patients could present mild, moderate or important (notably in the super obese patients) weight regain associated with comorbidity relapse motivating redo surgery. Like in revisional surgery, operating super-obese patient (BMI ≥50 kg/m2) is a challenge. It has been shown that achieving significant weight loss was more difficult in patients with a BMI ≥ 50 compared to lower BMIs.
Read the detailed description
In these 2 populations of patients, more malabsorptive procedures like long limb One Anastomosis Gastric Bypass or Bilio-Pancreatic Diversion with Duodenal Switch could be more efficient but induce technical difficulties (high complication rate) and can be responsible for malnutrition (vitamin deficiencies, hypoalbuminemia…). That's why, in case of revisional surgery or for high BMI patients,laparoscopic Roux-en-Y gastric bypass (RYGBP) is still considered as the gold standard and is the most performed intervention. To obtain better weight loss safely,Santoro et al. promoted the sleeve gastrectomy with transit bipartition (SG+TB), a new intervention coupling a SG without interrupting pathway through the duodenum and preserving the pylorus and a long biliary limb RYGBP.
Hypothesis: Because there is no duodenal and jejunal exclusion, malnutrition is expected to be less frequent after SG+TB compared to BPD/DS. Its anastomosis on the antrum makes SG+TB easier to perform in super-obese patient than standard RYGB but more efficient in term of weight loss. Compared to BPD/DS or SADI which involves dissection of the duodenum and the confection of a duodenojejunostomy, SG+TB is also expected to be easier then safer.
- Conditions
- Severe Obesity
- Being tested
- sleeve gastrectomy with transit bipartition (SG +TB), Roux-en-Y gastric bypass (RYGB)
- Keywords
- Severe obesity, Type 2 diabetes, Metabolic syndrome, Surgery, Malnutrition
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Type 2, Metabolic Syndrome, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomy with transit bipartition (SG +TB)Procedure or surgery
In case of a first intention procedure, a typical sleeve gastrectomy is performed, calibrated on a 36 French bougie, stapling starting 4 to 6 cm from the pylorus. Antecolic gastroileal anastomosis is performed 250 cm from the ileocecal transition, on the antrum using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 120 cm from the ileocecal junction. Thus, alimentary limb is 130cm and common limb 120cm.
Roux-en-Y gastric bypass (RYGB)Procedure or surgery
A small gastric pouch (30 cc) is performed. Antecolic gastroileal anastomosis is performed 200 cm from the Treitz junction, using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 50 cm from the Treitz junction. Thus, alimentary limb is 150cm and biliary limb 50cm.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic sleeve gastrectomy with transit bipartition (SG +TB) | Experimental | One arm benefiting from a laparoscopic sleeve gastrectomy with transit bipartition (SG +TB) Receives: Procedure: sleeve gastrectomy with transit bipartition (SG +TB) |
| laparoscopic Roux-en-Y gastric bypass (RYGB) | Sham comparator | One arm benefiting from a laparoscopic Roux-en-Y gastric bypass (RYGB) Receives: Procedure: Roux-en-Y gastric bypass (RYGB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Excess Weight Loss percentage (EWL%)
The Excess Weight Loss percentage (EWL%) calculated with the following formula: ((weight at 2 years visit - initial weight (kg)) / (initial weight - ideal weight)) X 100 Ideal weight defined as the weight corresponding to a BMI = 25 kg/m2. Initial weight defined as preoperative weight at V1. All weights are expressed in kg
Measured: at 2 years after surgery
Secondary outcomes (16)
Change nutritional status assessment
Nutritional profil : Hemoglobin (g/l), albumin (g/l), prealbumin (g/l)
Measured: from baseline (before surgery) to 24 months after surgery
Change in liver status assessment
Liver parameters ( ALT AST GGT Alkaline phosphatases, Total bilirubin, prothrombin time, urea, creatininemia concentration)
Measured: from baseline (before surgery) to 24 months after surgery
Change in vitamins status assessment
vitamins profil (vitamin A B1, B6 B9, B12, C , D and E concentration)
Measured: from baseline (before surgery) to 24 months after surgery
Change in mineral status assessment
Mineral profil ( ferritin, potassium, calcium,iron, transferrin, magnesium, selenium, zinc phophore concentration)
Measured: from baseline (before surgery) to 24 months after surgery
24-hour steatorrhea quantified at 6 months
24-hour steatorrhea is assessed to evaluate denutrition, expressed in g of lipid/24hr
Measured: At 6 months
Evolution of muscle mass assessed by bioelectrical impedance analysis
muscle mass is assessed to evaluate denutrition.
Measured: from baseline to 24 months after surgery
Evolution of muscle mass assessed by grip strength test.
muscle mass is assessed to evaluate denutrition.
Measured: from baseline to 24 months after surgery
Complications rate within 2 years according to Dindo-Clavien classification
complications rate is assessed to evaluate safety of the procedure
Measured: within 2 years
Length of hospital stay defined as the number of days of hospitalization
length of hospital stay for the surgical procedure
Measured: up to 2 week
Evolution from baseline to 24 months after surgery of HbA1c level, HDL, LDL and triglycerides
Evolution from baseline to 24 months after surgery of HbA1c level (expressed in %), fasting glycemia (expressed in mmol/l or g/l), HDL (expressed in mmol/l or g/l), LDL (expressed in mmol/l or g/l) and triglycerides (expressed in mmol/l)
Measured: from baseline to 24 months after surgery
Evolution from baseline to 24 months of insulinoresistance defined by HOMA-IR calculated with fasting blood glucose and fasting insulinemia12
assessment of insulinoresistance
Measured: from baseline to 24 months
Change of the GIQLI score
This questionnaire consists of 36 items exploring 5 dimensions or subscales: symptoms, physical condition, emotions, social integration and the effect of any medical treatment. For each item, 5 responses will be proposed to patients and for each answer, a score is assigned, ranging from 0 to 4 (highest score = 144). A high score defines a more favorable health state
Measured: from baseline to 24 months after surgery
Change of the SF36 scores
This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health.
Measured: from baseline to 24 months after surgery
Change in Sigstad questionnaire score (dumping syndrome).
The Sigstad questionnaire allows the identification and diagnosis of postoperative hypoglycemia: a score > 7 suggests a dumping and a score <4 suggests another diagnosis.
Complementary questions regarding timing of dumping (<30 min or >1h30) will be asked if Sigstad score >7.
Measured: from baseline to 24 months after surgery
Change of food choices and preferences assessed by the Leeds Food Preference Questionnaire (LFPQ) score.
The Leeds Food Preference Questionnaire provides measures of different components of food preference and food reward. Participants are presented with an array of pictures of individual food items common in the diet. Foods in the array are chosen by the experimenter from a validated database to be either predominantly high (>50% energy) or low (<20% energy) in fat but similar in familiarity, protein content, sweet or non-sweet taste and palatability. Outcome measured are explicit Liking, explicit wanting, implicit wanting and food choice.
Scores for explicit liking and explicit wanting range from 0-100 with a typical mean (±S.D.) of 60±18 Scores for Food Choice range from 0-48 and have a typical mean of 24±10 or for the appeal bias range from -48-48 with a typical mean of -5±15.
Scores for Implicit Wanting typically range from -100-100 (due to RT there is no fixed min-max value) and have a typical mean of ±10±25 or for the appeal bias a typical mean of -10±30.
Measured: from baseline to 24 months after surgery
Change of physical activity assessed by the International Physical Activity Index (IPAQ) score.
The International Physical Activity Questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives to estimate total physical activity in MET-min/week and time spent sitting.
Measured: from baseline to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start23 Jul 2021
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Robert CAIAZZO, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915014
- Sponsor's protocol ID
- 2020_10
- Other IDs
- 2020-A02656-33, PHRC-19-031
- Acronym
- BIPASS
- Status last verified
- Feb 2026
- First submitted
- 19 May 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Sleeve Gastrectomy With Transit Bipartition (SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB)
- ClinicalTrials.gov ID
- NCT04915014
- Acronym / sponsor ID
- BIPASS / 2020_10
- Conditions
- Severe Obesity
- Keywords
- Severe obesity, Type 2 diabetes, Metabolic syndrome, Surgery, Malnutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 7 Jun 2021 (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.
Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. Sleeve Gastrectomy (SG) has become the most performed intervention either worldwide or in France, where SG represents more than 60% of bariatric interventions and 114,817 patients operated between 2013 and 2016.
Maximum Excess weight loss (%EWL) after SG is obtained at one-year post surgery. Then it has been largely reported in the literature that patients could present mild, moderate or important (notably in the super obese patients) weight regain associated with comorbidity relapse motivating redo surgery. Like in revisional surgery, operating super-obese patient (BMI ≥50 kg/m2) is a challenge. It has been shown that achieving significant weight loss was more difficult in patients with a BMI ≥ 50 compared to lower BMIs.
Detailed description
In these 2 populations of patients, more malabsorptive procedures like long limb One Anastomosis Gastric Bypass or Bilio-Pancreatic Diversion with Duodenal Switch could be more efficient but induce technical difficulties (high complication rate) and can be responsible for malnutrition (vitamin deficiencies, hypoalbuminemia…). That's why, in case of revisional surgery or for high BMI patients,laparoscopic Roux-en-Y gastric bypass (RYGBP) is still considered as the gold standard and is the most performed intervention. To obtain better weight loss safely,Santoro et al. promoted the sleeve gastrectomy with transit bipartition (SG+TB), a new intervention coupling a SG without interrupting pathway through the duodenum and preserving the pylorus and a long biliary limb RYGBP.
Hypothesis: Because there is no duodenal and jejunal exclusion, malnutrition is expected to be less frequent after SG+TB compared to BPD/DS. Its anastomosis on the antrum makes SG+TB easier to perform in super-obese patient than standard RYGB but more efficient in term of weight loss. Compared to BPD/DS or SADI which involves dissection of the duodenum and the confection of a duodenojejunostomy, SG+TB is also expected to be easier then safer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic sleeve gastrectomy with transit bipartition (SG +TB) | Experimental | Procedure: sleeve gastrectomy with transit bipartition (SG +TB)One arm benefiting from a laparoscopic sleeve gastrectomy with transit bipartition (SG +TB) |
| laparoscopic Roux-en-Y gastric bypass (RYGB) | Sham comparator | Procedure: Roux-en-Y gastric bypass (RYGB)One arm benefiting from a laparoscopic Roux-en-Y gastric bypass (RYGB) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SG+TB or RYGB as a first intention procedure with BMI ≥40 kg/m2 or BMI ≥ 35 kg/m2 associated with one co-morbidity which will be improved by surgery (according to HAS 2009 recommendation3) OR as a second intention procedure (revisional surgery) after failure of Sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20%)).
- Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter Pylori (HP) and a HP eradication.
- 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
Key exclusion criteria (16 listed)
- History of previous bariatric surgery, other than a Sleeve Gastrectomy
- Patient with current BMI > 60 kg/m2
- Presence of a severe and evolutive life threatening pathology, unrelated to obesity
- History of Chronic inflammatory bowel disease
- Type 1 Diabetes
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 |
|---|---|---|
| sleeve gastrectomy with transit bipartition (SG +TB)In case of a first intention procedure, a typical sleeve gastrectomy is performed, calibrated on a 36 French bougie, stapling starting 4 to 6 cm from the pylorus. Antecolic gastroileal anastomosis is performed 250 cm from the ileocecal transition, on the antrum using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 120 cm from the ileocecal junction. Thus, alimentary limb is 130cm and common limb 120cm. | Procedure or surgery | laparoscopic sleeve gastrectomy with transit bipartition (SG +TB) |
| Roux-en-Y gastric bypass (RYGB)A small gastric pouch (30 cc) is performed. Antecolic gastroileal anastomosis is performed 200 cm from the Treitz junction, using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 50 cm from the Treitz junction. Thus, alimentary limb is 150cm and biliary limb 50cm. | Procedure or surgery | laparoscopic Roux-en-Y gastric bypass (RYGB) |
Primary outcome
The Excess Weight Loss percentage (EWL%)
Time frame: at 2 years after surgery
The Excess Weight Loss percentage (EWL%) calculated with the following formula: ((weight at 2 years visit - initial weight (kg)) / (initial weight - ideal weight)) X 100 Ideal weight defined as the weight corresponding to a BMI = 25 kg/m2. Initial weight defined as preoperative weight at V1. All weights are expressed in kg
16 secondary outcomes
Change nutritional status assessment
Time frame: from baseline (before surgery) to 24 months after surgery
Change in liver status assessment
Time frame: from baseline (before surgery) to 24 months after surgery
Change in vitamins status assessment
Time frame: from baseline (before surgery) to 24 months after surgery
Change in mineral status assessment
Time frame: from baseline (before surgery) to 24 months after surgery
24-hour steatorrhea quantified at 6 months
Time frame: At 6 months
Evolution of muscle mass assessed by bioelectrical impedance analysis
Time frame: from baseline to 24 months after surgery
Evolution of muscle mass assessed by grip strength test.
Time frame: from baseline to 24 months after surgery
Complications rate within 2 years according to Dindo-Clavien classification
Time frame: within 2 years
Length of hospital stay defined as the number of days of hospitalization
Time frame: up to 2 week
Evolution from baseline to 24 months after surgery of HbA1c level, HDL, LDL and triglycerides
Time frame: from baseline to 24 months after surgery
Evolution from baseline to 24 months of insulinoresistance defined by HOMA-IR calculated with fasting blood glucose and fasting insulinemia12
Time frame: from baseline to 24 months
Change of the GIQLI score
Time frame: from baseline to 24 months after surgery
Change of the SF36 scores
Time frame: from baseline to 24 months after surgery
Change in Sigstad questionnaire score (dumping syndrome).
Time frame: from baseline to 24 months after surgery
Change of food choices and preferences assessed by the Leeds Food Preference Questionnaire (LFPQ) score.
Time frame: from baseline to 24 months after surgery
Change of physical activity assessed by the International Physical Activity Index (IPAQ) score.
Time frame: from baseline to 24 months 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 10 Feb 2026.
Related trials for Severe Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
RecruitingPhase 3
Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
Crohn's Disease, Obesity or Overweight
RecruitingPhase 3
Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
Ulcerative Colitis, Obesity or Overweight
Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
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. This study is not recruiting at the moment.
Robert CAIAZZO, MD,PhD principal investigator
University Hospital, Lille
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleeve gastrectomy with transit bipartition (SG +TB) and Roux-en-Y gastric bypass (RYGB) in people with Severe Obesity, run by University Hospital, Lille at 8 sites 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 5 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Excess Weight Loss percentage (EWL%) (time frame: at 2 years after surgery). 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 10 Feb 2026.