跳至主要内容
临床试验/NCT07186959
NCT07186959Enrolling By Invitation不适用

A Novel Endoscopic Gastric Purse-string Suture Device for Weight Management in an in Vivo Human Model

Liu Yan1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
15
试验地点
1
主要终点
Percent Total Weight Loss (%TWL) measured by calibrated digital scale

研究概览

简要总结

ndoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management. Mucosal ablation of the gastric fundus has been reported to limit fundic expansion and promote satiety; however, ablation can cause perforation, infection, bleeding, and other complications. To restrain fundic expansion while minimizing surgical trauma and preserving reversibility, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce gastric volume. This procedure may be suitable for short-term weight management. Safety and feasibility were demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

详细描述

The global prevalence of obesity has increased over the past five decades. Endoscopic bariatric and metabolic therapies (EBMTs) have introduced more convenient, minimally invasive, and safe approaches to weight management and have emerged as promising alternatives for treating obesity and related metabolic disorders (including type 2 diabetes and nonalcoholic fatty liver disease). Christopher et al. reported that ablation of the gastric fundus mucosa induces mucosal fibrosis; the resulting fibrotic tissue impedes fundic expansion and promotes satiety. However, fundic mucosal ablation may cause extensive and irreversible injury, increasing the risks of perforation, infection, bleeding, and other complications. A minimally invasive endoscopic therapy that inhibits fundic expansion while minimizing surgical trauma and preserving reversibility is therefore desirable.

Based on this rationale, an endoscopic gastric purse-string suturing (EGPSS) technique was developed to reduce the volume of the gastric fundus. EGPSS employs a specially designed endoclip in combination with an endoloop to appose the fundic mucosa and restrict fundic expansion. This procedure may be suitable for short-term weight management. Safety and feasibility have been demonstrated in a porcine model. The present study will evaluate the feasibility of EGPSS in participants with obesity and assess histological and physiological outcomes.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with a body mass index (BMI) of 24-35 kg / m²;
  • •Patients accepted Lifestyle modifications, pharmacological interventions for weight loss which were unsuccessful or experienced a weight rebound;
  • •Patients willing to loss weight;
  • •Obese patients with metabolic disorders.

排除标准

  • •Women who are planning to conceive, pregnant, or breastfeeding;
  • •Patients who are suffering from severe organ failure requiring hospitalization;
  • •Patients who have undergone gastrectomy;
  • •Patients allergic to anesthetics.

研究组 & 干预措施

Operation group

Experimental

Patients will undergo endoscopic gastric purse-string suturing procedure under endoscope by skilled endoscopist

干预措施: endoscopic gastric purse-string suturing (Procedure)

结局指标

主要结局

Percent Total Weight Loss (%TWL) measured by calibrated digital scale

时间窗: Baseline and 3 months post-procedure

Body weight recorded using a calibrated digital scale (kg). %TWL calculated as (baselineweight-follow-upweight)÷baselineweight × 100%. Measurements obtained under fasting conditions, light clothing, no shoes.

次要结局

  • Percent Excess Weight Loss (%EWL) measured by calibrated digital scale(Baseline and 3 months)
  • Satiety score (100-mm Visual Analog Scale, VAS) after standardized liquid meal(Baseline and 3 months)
  • Gastric fundus volume (magnetic resonance imaging, MRI)(Baseline and 3 months)
  • Fasting plasma ghrelin and leptin (ELISA)(Baseline and 3 months)
  • Insulin resistance (HOMA-IR)(Baseline and 3 months)
  • Procedure-related adverse events (ASGE lexicon severity grading)(Day 0 to Month 3)

研究者

发起方
Liu Yan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Liu Yan

Director, Head of Gastroenterology, Principal Investigator, Clinical Professor

Beijing 302 Hospital

研究点 (1)

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