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New treatment option for Morbid Obesity
Official title Gastric Recalibration After Endoscopic Sleeve Gastroplasty
ClinicalTrials.gov ID: NCT04945473
What this study is testing
- What it's testing
- Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique.
- 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 75
You may be able to join if
- Patients aged 18 to 75
- Patients with morbid obesity (BMI≥ 30 with comorbidities or\> 40)
- Patients with obesity for more than 2 years
- Failure of medical treatment of obesity
- Patients who may benefit from general anaesthesia
You likely can't join if
- Patient with a contraindication to perform an ESG
- Patient with a history of previous bariatric, gastric or esophageal surgery.
- Patient who initiated medical therapy within the last 3 months, with evidence of weight gain.
- Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
- Patient with unstable and precarious state of health, as determined and assessed by the investigator.
- Patient who is pregnant, breastfeeding or of childbearing age and without effective contraception.
See the full eligibility criteria
- Patients aged 18 to 75
- Patients with morbid obesity (BMI≥ 30 with comorbidities or\> 40)
- Patients with obesity for more than 2 years
- Failure of medical treatment of obesity
- Patients who may benefit from general anaesthesia
- Patient able to participate in all aspects of the study and that agree to comply with all study requirements, for the duration of the study. This includes the availability of reliable transportation and sufficient time...
- Patient able to fully understand the study and ready to give consent to participate to the study.
- Patient affiliated to the French social security system
- Patient with a contraindication to perform an ESG
- Patient with a history of previous bariatric, gastric or esophageal surgery.
- Patient who initiated medical therapy within the last 3 months, with evidence of weight gain.
- Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
- Patient with unstable and precarious state of health, as determined and assessed by the investigator.
- Patient who is pregnant, breastfeeding or of childbearing age and without effective contraception.
- Patient in exclusion period (determined by a previous or ongoing study)
- Patient under legal protection
- Patient under guardianship or curatorship
- Patients with a BMI less than 30 at 6 months after ESG. These patients will not be candidate for revision regardless of the randomization group.
- Patients with a contraindication to MRI may be included in the study and will follow the "No Imaging" study design.
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, 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.