Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Total Body Weight Loss
研究概览
简要总结
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.
详细描述
Obesity, particularly morbid obesity, is a major public health issue in France. According to the latest data from the ObÉpi-Roche 2020 survey, more than 17% of French adults are obese. Obesity is a well-established risk factor for many chronic diseases such as type 2 diabetes, cardiovascular disease, high blood pressure (HBP), musculoskeletal disorders, certain cancers, and non-alcoholic steatohepatitis (NASH). It is associated with a significant reduction in life expectancy and represents a direct cost estimated at more than €5 billion per year for the French healthcare system.
While bariatric surgery (particularly sleeve gastrectomy and gastric bypass) remains the gold standard treatment for severe obesity, it is invasive, costly, and only offered to a minority of patients (less than 10% of eligible patients). In addition, certain medical contraindications, refusal of surgery, and waiting times limit access to this treatment.
Endoscopic sleeve gastroplasty ("Endosleeve"). Endoscopic sleeve gastroplasty (ESG) is an innovative, non-surgical, natural procedure that reduces stomach volume without resection or anastomosis. It has shown promising results in terms of weight loss, metabolic improvement, and safety, while being reversible and reproducible. The MERIT randomized controlled trial in USA (JAMA, 2022) demonstrated an average weight loss of 13.6% of total body weight at 12 months (vs. 0.8% in the control group), as well as a significant improvement in comorbidities such as type 2 diabetes and hypertension.
Hypothesis and objective of the study The hypothesis of this study is that ESG, when performed under routine care conditions in the United States, leads to significant and sustainable weight loss, associated with an improvement in comorbidities, with a favorable safety profile. The main objective of this project is therefore to evaluate, on a national scale, the clinical efficacy, safety, and procedural variability of ESG through a multicenter real-world cohort.
To date, no large-scale French study has analyzed the results of ESG in real-world settings. This hinders its integration into national healthcare pathways, its reimbursement by the French national health insurance system, and its wider adoption by the medical community. The question raised-the rigorous evaluation of ESG in the French context-therefore remains unanswered.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Patients who can undergo general anesthesia.
- •Patients who are able to participate in all aspects of the study and agree to comply with all study requirements for the entire duration of the study.
- •Patients who are able to fully understand the study and are willing to give their consent to participate in the study.
- •Patients affiliated with the French social security system.
排除标准
- •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.
- •Patients with a history of uncontrolled, poorly controlled, or suspected eating disorders or psychiatric illness.
- •Patients with unstable and precarious health, as determined and assessed by the investigator.
- •Patients who are pregnant, breastfeeding, or of childbearing age and not using effective contraception.
- •Patients who are currently excluded (as determined by a previous or ongoing study).
- •Patients under judicial protection.
- •Patients under guardianship, conservatorship or subject to any form of protective supervision
研究组 & 干预措施
All adult patients with obesity scheduled for endoscopic gastroplasty (ESG)
干预措施: Endoscopic sleeve gastroplasty (Procedure)
结局指标
主要结局
Total Body Weight Loss
时间窗: At the inclusion and 24 months after procedure
Assessment of weight loss in terms of total body weight loss (TBWL, %) 24 months after surgery
次要结局
- Excess weight loss(At the inclusion and 24 months after procedure)
- Body Mass Index (BMI)(From ESG procedure to the end of participation at 24 months post-procedure)
- Adverse events(From ESG procedure to the end of participation at 24 months post-procedure)
- Comorbidities improvement(From ESG procedure to the end of participation at 24 months post-procedure)
- Quality of life improvement(From ESG procedure to the end of participation at 24 months post-procedure)
- Additional treatments(From ESG procedure to the end of participation at 24 months post-procedure)