BridgeMD
Compares treatment options for Obesity
Official title Omega Gastric Bypass (150cm) Compared to the Roux-en-Y Gastric Bypass (YOMEGA-2 Multicentric Trial)
ClinicalTrials.gov ID: NCT06057597
What this study is testing
- What it's testing
- Obesity with its consequences such as type 2 diabetes, high blood pressure, dyslipidemia, fatty liver disease, sleep apnea and cancers, remains a major healthcare problem worldwide. Bariatric surgery, combined with nutritional education and close monitoring, has been shown to be the most effective treatment for patients with morbid obesity resulting in significant and lasting weight loss and improvements in co-morbidities .
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patient aged from 18 to 65 years old
- Type III obesity (BMI ≥ 40 kg/m²), or Type II obesity BMI 35-40 kg/m2 associated with at least one co-morbidity which will be improved by surgery...
- Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter pylori within 12 months before surgery
- Patient who has benefited from a multidisciplinary evaluation at least 6 months, with a favorable opinion for a gastric bypass
- Patient who understood and accepted the need for a long-term follow-up
You likely can't join if
- History of previous bariatric surgery
- History of chronic inflammatory bowel disease
- Presence of chronic diarrhea
- Presence of a severe and evolutive life threatening pathology
- Presence of dysplastic modifications of the gastric mucosa, chronic atrophic gastritis or history of gastric cancer
- Presence of an unhealed gastro-duodenal ulcer
See the full eligibility criteria
- Patient aged from 18 to 65 years old
- Type III obesity (BMI ≥ 40 kg/m²), or Type II obesity BMI 35-40 kg/m2 associated with at least one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea...
- Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter pylori within 12 months before surgery
- Patient who has benefited from a multidisciplinary evaluation at least 6 months, with a favorable opinion for a gastric bypass
- Patient who understood and accepted the need for a long-term follow-up
- Patient who agreed to be included in the study and who signed the informed consent form
- Patient affiliated to a social security scheme
- For child-bearing aged women, efficient contraception
- History of previous bariatric surgery
- History of chronic inflammatory bowel disease
- Presence of chronic diarrhea
- Presence of a severe and evolutive life threatening pathology
- Presence of dysplastic modifications of the gastric mucosa, chronic atrophic gastritis or history of gastric cancer
- Presence of an unhealed gastro-duodenal ulcer
- Presence of Helicobacter pylori resistant to medical treatment
- Presence of esophagitis
- Pregnancy or desire to be pregnant during the study
- Mentally unbalanced patients, under supervision or guardianship
- Patients who don't understand French and not able to give consent
- Patient included and followed in another treatment trial
- Unable to consent, under tutelage or curatorship, or judiciary safeguard
- Presence of type 1 diabetes
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.