Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline Bariatric Quality of Life (BQL) Questionaire
研究概览
简要总结
The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves durability of the procedure.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) between 30 and 40
- •Age >18 and ≤50
- •Stable weight for 3 months (within 5% of BMI)
- •Normal basic labs (CBC, chemistry profile, creatinine)
- •Negative pregnancy test for females >18 or ≤ 50
排除标准
- •Unstable coronary artery disease
- •Heart failure
- •Cardiac arrhythmia
- •Cardiac valvular disease
- •Obstructive of interstitial lung disease
- •Females of child-bearing age >18 or ≤ 50 who are pregnant or lactating
- •Mallampati score of 4
- •ASA 3 or above
- •Previous gastric surgery
- •Ulcer disease
- •Gastroparesis,
- •> 5 cm Hiatal hernia
- •Congenital anomalies of the GI tract
- •Currently on or prescribed a medication known to affect weight within 3 months of study entry.
研究组 & 干预措施
Botulinum toxin at injection site
All subjects will have gastroplasty performed using the Overstitch Endoscopic Suturing System. Botulinum toxin will be injected in every other suture site in half of the randomly patients selected.
干预措施: Botulinum toxin (Drug)
Botulinum toxin at injection site
All subjects will have gastroplasty performed using the Overstitch Endoscopic Suturing System. Botulinum toxin will be injected in every other suture site in half of the randomly patients selected.
干预措施: Overstitch Endoscopic Suturing System (Device)
结局指标
主要结局
Change from baseline Bariatric Quality of Life (BQL) Questionaire
时间窗: baseline to 3 months
次要结局
- Change from baseline Three factor Eating Questionnaire (TFEQ-R21)(baseline to 3 months)
研究者
Barham K. Abu Dayyeh, M.D.
Principal Investigator
Mayo Clinic