Prospective Multicenter Study to Assess the Safety and Efficacy of the Endomina® Triangulation Platform for Treating Patients Requiring Endoscopic Gastroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Safety outcome
研究概览
简要总结
This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of "real life" routine clinical practice
详细描述
This is a single arm prospective, multi-center international, open-label, non-interventional, , post-market study. This registry is designed to further assess on a larger scale safety and efficacy of the endomina® and TAPES devices. Patients in need of endoscopic gastroplasty will be enrolled and followed-up for 36 months following hospital routine practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient must be willing to provide written informed consent
- •Adult patients (between ≥ 18 years (legal age in Europe) and 65 years of age at time of ESG)
- •Patients who require endoscopic gastroplasty and who are selected by multidisciplinary team/investigators to be treated with the endomina® device and accessories according to the Instructions for Use (IFU)
排除标准
- •Patients with impaired hemostasis or pre-existing conditions that may lead to fragile mucosa (i.e., any contraindication to suturing the stomach)
- •Any malformation from mouth to esophagus (including pharynx)
- •Any contraindication to general anesthesia, including patients with cardiorespiratory dysfunction or respiratory failure
- •Woman who are pregnant, at the time of the procedure or planning (trying) to become pregnant, or nursing within 12 months after the procedure.
- •Impending surgery 60 days post intervention of the treated section of the GI tract
- •Participation in another clinical study evaluating another medical device, another procedure or a medication that did not reach its primary endpoint
结局指标
主要结局
Safety outcome
时间窗: 12 months
Occurrence of Serious Adverse Device Effects at 12 months.
Technical success
时间窗: 1 day
Technical success defined by the completion of the intended procedure without premature abortion due to technical reasons/device deficiency
次要结局
未报告次要终点