NL-OMON46714已完成不适用
Single center, prospective, single-arm feasibility study to evaluate the safety of the PlenSat Digestible Balloons in the treatment of Obesity - Safety of PlenSat Digestible Balloons in Humans
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •18-80 years of age
- •Able and willing to sign an informed consent document
- •BMI of 30-39.9 kg/m^2
- •Sufficient and stable medical health
- •Must have a primary care physician
排除标准
- •Signs/symptoms of gastroduodenal ulcer disease (in history or present)
- •Poorly controlled diabetes or diabetes >10yr
- •Signs/symptoms of oesophageal or gastric disease (in history or present)
- •Signs/symptoms of dysmotility of gastrointestinal tract
- •Use of opioid drugs (past six weeks or present)
- •Female subject is pregnant or suspected to be pregnant, or lactating
- •Previous bariatric, gastric or oesophageal surgery
- •Swallowing disorders
- •Illicit drug use or alcohol abuse
- •Participation in other clinical study within past 4 weeks
研究者
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