NCT01753609Unknown不适用
Safety and Performance Evaluation of TrimWeight Device - an Intragastric Auto-inflating & Degradable Balloon in a Swallow-able Capsule ("the Device"), for Enhancing Satiety and Satiation in Healthy Over Weight and Obese Volunteers
Tulip Medical Ltd.2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of subjects with device related serious adverse events
研究概览
简要总结
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon
详细描述
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon, packed in a swallow-able capsule, in healthy subjects with 30 < BMI≤ 35.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 ≤ Age <65 years
- •30 < BMI ≤ 35 kg/m2
- •Healthy without any medication;
- •No history of weight reduction of more than 5% of total body weight in the past 6 months;
- •Normal blood count and chemistry;
- •Hemoglobin level over 11;
- •At least 3 bowel movements per week;
- •Subject declares that he/she is able to go through gastroscopic examination;
- •Subject is able and willing to give informed consent and follow protocol procedures.
排除标准
- •Any history or evidence of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results;
- •History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit);
- •History or symptoms of thyroid disease which is not controlled by medication;
- •Abnormal gastrointestinal findings: Diaphragmatic hernia > 3 cm; Active peptic ulcer; Erosive gastritis; Gastric outlet obstruction;
- •Subject with IBD
- •Significant swallowing disorders;
- •Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy);
- •Malabsorption disorders.
- •Is taking medications that reduce gastric acidity
- •Currently using pharmaceutical agents or food supplements for weight loss;
- •History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
- •History of food Allergy;
- •Subject with poor venous access;
- •Is taking chronic aspirin or other non-steroidal anti-inflammatory agents, or other medications known to be gastric irritants;
- •Have any coagulation problem and/or taking any anticoagulant medications;
- •Evidence of current malignant disease;
- •Have history of any acute disease (viral, bacterial, pain, accident) in the last 6 weeks.
- •Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study;
- •Inability to give written informed consent;
- •History of alcohol or drug abuse within 6 months of screening;
- •Mental disorders;
- •Currently participating in an ongoing clinical study
- •Any reasons making the patient a poor candidate in the opinion of the investigator.
结局指标
主要结局
Number of subjects with device related serious adverse events
时间窗: 36 days
Safety will be assessed descriptively by summarizing device related SAEs, gastroscopic examination, daily diary, vital sign measurements, physical examination and abdomen circumference.
次要结局
- Patient assessment of capsule tolerability(36 days)
- Satisfying evacuation of the balloon from the stomach after oral intake(36 days)
研究者
研究点 (2)
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