NCT02003872终止不适用
The Long Term Effect of Adjustable Spaatz 3 Intragastric Balloon on Weight Loss
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Excess weight loss
研究概览
简要总结
This is an open-label trial investigating the effect of Spatz 3 intragastric balloon on weight loss on obesity and associated co- morbidities.
The study aim is to evaluate the effect of the intra gastric balloon on weight reduction and on related co- morbidities during 1 year of balloon implantation and a year following explantation.
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
- •Subjects willing to comply with study requirements and have signed an informed consent form.
- •BMI ≥ 35 kg/m² or BMI ≥ 30 kg/m² and hypertension or diabetes mellitus
- •Documented negative pregnancy test in women of childbearing potential.
- •Women of childbearing potential agree to remain on contraceptives for the duration of their trial participation.
排除标准
- •Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to randomization (including GLP-1 analogs).
- •Previous GI surgery that could preclude the ability to place the device.
- •Subjects with a history of abnormal GI anatomical findings documented on imaging study, which in the opinion of the investigator, may impair implantation of the IGB device
- •Subjects with severe GERD that are not responding to Proton Pump Inhibitor (PPI)
- •Known abnormal pathologies or conditions of the upper gastrointestinal tract.
- •Subjects with symptomatic gallstones within 6 months prior to randomization
- •Coagulopathy defined as hgb <10g/dl and platelet < 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities
- •Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent)
- •Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) or any other drugs with bleeding as a potential side effect during the study duration.
- •Subject is or has been enrolled in another investigational study within 3 months of participation into the current study
- •Subjects not residing within a 3 hour driving distance of the study center.
结局指标
主要结局
Excess weight loss
时间窗: 2 years
次要结局
- liver fat infiltration(2 years)
研究者
Dr. Alon Lang
Senior physician GI department
Sheba Medical Center
研究点 (2)
Loading locations...
相似试验
已完成
3 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) PatientsDiarrheaHIV InfectionsNCT00002408Shaman Pharmaceuticals300
已完成
不适用
A Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese SubjectsOverweightObesityNCT02487602Gelesis, Inc.16
已完成
2 期
A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese SubjectsObesityNCT00537420Nastech Pharmaceutical Company, Inc.551
已完成
不适用
Obalon Balloon System Pivotal IDE (SMART) TrialObesityNCT02235870Obalon Therapeutics, Inc.711
进行中（未招募）
3 期
Breast Cancer WEight Loss Study (BWEL Study)Breast CarcinomaBreast Ductal Carcinoma In SituInvasive Breast CarcinomaStage II Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage IIIA Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7Synchronous Bilateral Breast CarcinomaNCT02750826Alliance for Clinical Trials in Oncology3,177