Gastric Recalibration After Endoscopic Sleeve Gastroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endoscopic Sleeve Gastroplasty

NCT02948621

Morbid Obesity

COMPLETED

Glucose-homeostasis After Endoscopic Sleeve Gastroplasty

NCT04063098

Obesity, Morbid

COMPLETED NA

Endoscopic Gastric Tubulization

NCT03554902

Morbid Obesity

RECRUITING

Endoscopic Sleeve Gastroplasty for Moderate Obesity

NCT05750134

Obesity

UNKNOWN

Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin

NCT04344847

Excision Margin

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Obesity is a health dilemma with an increased risk of premature death. Bariatric surgery is considered to be the most effective and durable treatment for morbid obesity as compared to other available options. However, only the most severe cases, namely class III or class II patients with obesity-related comorbidities fit the criteria for bariatric surgical interventions and are offered these options. Endoscopic sleeve gastroplasty (ESG) is a restrictive procedure based on the tubulization and shortening of the stomach, achieved by means of multiple full-thickness sutures applied endoscopically. ESG offers the possibility to obtain results (weight loss, improvement of comorbidities and quality of life) comparable to conventional surgery while reducing the risk of complications. One of the major advantages of this technique is that it does not make irreversible changes to gastric anatomy and function and can be repeated overtime if needed placing additional sutures. ESG appearance might be subject to changes overtime. In fact, depending on the sutures' integrity, the gastroplasty can be regarded as tight, partially open or completely open. Very little data currently exists in the literature on the effectiveness of endoscopic "revision" with the placement of additional sutures on weight loss and its impact on co-morbidities. In order to objectively assess the benefits and costs of a revision during the follow-up endoscopy patients who present a TWL \<10% or a BMI greater than 30 at 6 months from the primary ESG, will be randomized into 2 groups: a "Revision" group in which a revision will be performed systematically in the event of suture disruption at the control EGD, and a "Control" group which will only benefit of a control endoscopy regardless of the state of the gastroplasty.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morbid Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Revision

BMI≥30 or total weight loss (TBWL) \< 10% and relaxation of gastric tubulisation at 6 months after ESG.

Additional stitches will be placed during the follow-up gastroscopy at 6 months.

Group Type EXPERIMENTAL

Endoscopic placement of additional sutures

Intervention Type PROCEDURE

A new endoscopic suture will be performed in case of a BMI≥30 or total weight loss (TBWL) less than 10%, and relaxation of gastric tubulization during the regular endoscopic follow-up after 6 months from the ESG. The same endoscopic suture technique of the primary ESG will be applied.

Without revision

The control gastroscopy will be performed without any additional procedure (no additional stitches).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic placement of additional sutures

A new endoscopic suture will be performed in case of a BMI≥30 or total weight loss (TBWL) less than 10%, and relaxation of gastric tubulization during the regular endoscopic follow-up after 6 months from the ESG. The same endoscopic suture technique of the primary ESG will be applied.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No