Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorIHU Strasbourg
About this trial
EGO-Trial is the first multicenter study in France which aims to evaluate the efficacy of Endoscopic Sleeve Gastroplasty (ESG) in patients with obesity. This project fills a critical national gap by providing real-world, multicentric data from diverse French healthcare settings, offering insight into the safety, efficacy, and variability of ESG practices across institutions
The project is expected to generate robust, multicentric clinical evidence on the safety and efficacy of ESG in patients with obesity within the French healthcare context.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 75 years.
Patients with a Body Mass Index (BMI) ≥ 30 kg/m².
Patients who have failed non-surgical weight loss interventions (diet, exercise, pharmacological therapy).
Patients not eligible for bariatric surgery or does not wish to undergo it.
Disqualifiers
Patients with contraindications to endoscopic gastroplasty
Patients with active peptic ulcer disease or significant gastroparesis
Patients with a history of bariatric, gastric, or esophageal surgery.
Patients who have started medication in the last 3 months that is known to cause weight gain.
Trial population
Adult patients with obesity scheduled for endoscopic gastroplasty
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Endoscopic sleeve gastroplasty
Procedure/SurgeryEndoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device which allows for a reduction in stomach volume without resection or anastomosis
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: All adult patients with obesity scheduled for endoscopic gastroplasty (ESG)1 intervention
Trial outcomes
Primary outcomes
1
Total Body Weight Loss
Assessment of weight loss in terms of total body weight loss (TBWL, %) 24 months after surgery
Time frame
At the inclusion and 24 months after procedureSecondary outcomes
1
Excess weight loss
Assessment of weight loss in terms of excess weight loss (EWL, %) at 24 months post-procedure
Time frame
At the inclusion and 24 months after procedure2
Body Mass Index (BMI)
Assessment of weight loss in terms of change in Body Mass Index (BMI) at 24 months post-procedure
Time frame
From ESG procedure to the end of participation at 24 months post-procedure3
Adverse events
Rate of minor and major adverse events (e.g., perforation, delayed gastric emptying, reflux symptoms) throughout follow-up for up to 24 months post-procedure
Time frame
From ESG procedure to the end of participation at 24 months post-procedure4
Comorbidities improvement
Assessment of improvement in comorbidities (type 2 diabetes, hypertension, dyslipidemia, sleep apnea) and obesity-related complications over 24 months using the SF-BARI (Swiss-Finnish BARIatric metabolic outcome score) questionnaire: a score developed to evaluate treatment outcomes in obesity management
Time frame
From ESG procedure to the end of participation at 24 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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