Gastric Recalibration After Endoscopic Sleeve Gastroplasty
Gastric Recalibration After Endoscopic Sleeve Gastroplasty
Recruiting
N/AInterventional Study
Morbid Obesity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
100 (estimated)
Sponsor
IHU Strasbourg · Other
Who this trial is looking for
This trial is looking for people aged 18 to 75 with morbid obesity who have not had success with other weight loss methods. Participants will be assessed for a possible follow-up procedure after their initial treatment.
Are You a Good Fit for This Trial?
Rules you outEating disordersUncontrolled health conditions
You may be able to join if
I am between 18 and 75 years old.
I have morbid obesity (BMI≥ 30 with health issues or >40).
I have been obese for more than 2 years.
I have not succeeded with medical treatments for obesity.
I can tolerate general anaesthesia.
I can attend all follow-up visits and understand what the study involves.
I am part of the French social security system.
You may not be able to join if
I cannot have an Endoscopic Sleeve Gastroplasty (ESG).
I have had previous bariatric, gastric, or esophageal surgery.
I started weight-loss medication in the last 3 months and have gained weight.
I have uncontrolled eating disorders or other psychiatric conditions.
I am currently in poor health as confirmed by the researcher.
I am pregnant, breastfeeding, or at childbearing age without effective contraception.
I am part of an exclusion period from another study.
I am under legal protection or guardianship.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revisi…
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. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.
Trial Locations
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Eligibility Criteria
Inclusion 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 o…
Inclusion 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 to attend all follow-up visits.
* 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
Exclusion Criteria:
* 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.
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