Safety and Efficacy of Endoscopic Sleeve Gastroplasty in Obese Children and Adolescents
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
In this study, the investigators assess the safety and efficacy of endoscopic sleeve gastroplasty in adolescents with obesity.
详细描述
Endoscopic bariatric therapy (EBT) is an emerging, rapidly evolving field that aims to serve as a middle ground between safe, albeit poorly effective medical weight loss strategies and drastic but effective bariatric surgery. Endoscopic sleeve gastroplasty (ESG) is a procedure that restricts the stomach to a sleeve-like configuration by utilizing full-thickness sutures that plicate the greater curvature of the stomach. Emerging data from adult populations shows an acceptable safety, tolerability and efficacy profile. Based on analysis that confirmed the safety and efficacy of ESG in adult patients who undergo the procedure under a standardized protocol and clinical care pathway, the investigators planned to study its effects on adolescents in a specialized center that offers surgical, endoscopic, and medical management of obesity under a standardized protocol and care pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI that is >120% of the 95th percentile for age and gender
- •Written informed assent/consent, with concomitant parental consent for patients aged ≤17 years
排除标准
- •Age <10 years
- •Age >21 years
- •Presence of large hiatal hernia
- •Previous gastric surgery
- •Cognitive impairment
研究组 & 干预措施
Adolescent Endosleeve
Patients who will undergo endoscopic sleeve gastroplasty
干预措施: Endoscopic Sleeve Gastroplasty (Procedure)
结局指标
主要结局
Weight Loss
时间窗: One year
% total weight loss
Adverse events
时间窗: One year
Adverse events, including hospitalization, or unplanned intervention
次要结局
未报告次要终点
研究者
Aayed Alqahtani
Professor of Surgery, Director of Obesity Chair
King Saud University