Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in body weight after various endoscopic bariatric therapies
研究概览
简要总结
This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe]) as clinically indicated, and subsequent follow up clinic visits for up to one year.
详细描述
The purpose the research is to better understand the effects of endoscopic bariatric therapy (EBT) on the weight change, hormonal changes and changes in the quality of life parameters for patients undergoing endoscopic bariatric procedures.
The primary research procedures are:
- EBT procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe])
- Behavioral intervention consisting of diet therapy, exercise therapy, and behavior modification
- Collection of blood to evaluate changes in hormonal profiles
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are considering undergoing EBT for weight loss
- •Patients with a BMI >30 kg/m2 (without obesity related comorbidities)
- •Patients with a BMI >27 kg/m2 (with obesity related comorbidities)
- •Patients willing and able to comply with study requirements for follow-up
- •Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight
- •Individuals 18 years old or older are included
排除标准
- •Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- •Esophageal, gastric or duodenal malignancy
- •Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
- •Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
- •Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
- •General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the investigator
- •Pregnant or planning to become pregnant during period of study participation
- •Patient refuses or is unable to provide written informed consent
- •Prior surgical or endoscopic anti-reflux procedure
- •Patients who are unwilling or unable to comply with the follow-up study schedule
结局指标
主要结局
Changes in body weight after various endoscopic bariatric therapies
时间窗: Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure
The investigators will compare mean percentage total body weight loss to baseline, at 1 month, 3 months, 6 months and 1 year post procedure.
次要结局
- Changes in hormonal profiles after various endoscopic bariatric therapies(Baseline/pre-procedure, 3 months, 6 months)
研究者
Kenneth Park
MD, Assistant Professor of Medicine Cedars-Sinai Medical Center
Cedars-Sinai Medical Center