NCT01422941已完成1 期
A PROSPECTIVE, MULTI-CENTER CLINICAL EVALUATION TO ASSESS SAFETY AND PERFORMANCE OF CAVU MEDICAL, INC.'S ATTUNE TUBING WHEN USED WITH NEWLY-IMPLANTED LAPAROSCOPIC ADJUSTABLE GASTRIC BANDS (LAGBs)
Cavu Medical, Inc.4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.
研究概览
简要总结
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is at least 18 years of age.
- •The subject has been informed of the nature of the trial and agrees to its provisions.
- •The subject has a pre-implantation BMI within the protocol limits.
- •The subject agrees to the follow-up visit schedule.
- •The subject is a candidate for a LAGB procedure.
- •The subject agrees to comply with specified follow-up evaluations.
- •The subject is willing to fast for 2 hours prior to each adjustment visit.
排除标准
- •The subject is pregnant or is not willing to use an effective method of birth control for the duration of the trial.
- •The subject has a condition that is contraindicated for LAGB procedures.
- •The subject is currently using weight loss medications or supplements.
- •The subject has a concurrent terminal medical condition with a life expectancy of less than 12 months.
- •The subject is currently participating in an investigational drug or another medical device trial.
- •The subject had a previous LAGB procedure.
- •The Investigator believes that the patient has physical or mental conditions that would render trial participation inappropriate.
结局指标
主要结局
The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.
时间窗: 30 Days
次要结局
未报告次要终点
研究者
研究点 (4)
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