A Prospective, Multicenter, Single-Arm, Pre-Market, Pivotal Study to Evaluate Safety and Efficacy of a Novel Motorized Spiral Enteroscope for Antegrade Enteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rate of device related serious adverse events
研究概览
简要总结
To evaluate safety and efficacy
详细描述
The purpose of this study is to evaluate the safety and efficacy of the PowerSpiral™ Enteroscopy System, when used in subjects undergoing antegrade (per-oral) enteroscopy of the small bowel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 22 years of age
- •Medical indication for antegrade enteroscopy
- •Willing and able to provide informed consent
排除标准
- •Any medical contraindication to standard enteroscopy
- •Any test that is done as part of the standard of care that would prevent the enteroscopy from being performed for safety reasons
- •Unable or unwilling to provide informed consent
- •Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
- •Presence of any intra-luminal or extra-luminal foreign body in the abdominal cavity
- •Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)
- •Known or suspected bowel obstruction, or history of bowel obstruction
- •Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
- •Known coagulation disorder
- •Known or suspected esophageal stricture or Schatzki ring
- •Known gastric or esophageal varices
- •Suspected perforation of the gastrointestinal (GI) tract
- •Previous abdominal radiation
- •Inability to tolerate general anesthesia for any reason
- •Inability to tolerate endotracheal intubation
- •Known need for endoscopic retrograde cholangiopancreatography (ERCP) during enteroscopy
- •American Society of Anesthesiologists (ASA) Classification 4 or greater
结局指标
主要结局
Rate of device related serious adverse events
时间窗: 7 days
The primary safety endpoint will compare the rate of device related serious adverse events (SAE) reported in this study to the rate of device related SAEs reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube
Maximum depth of endoscope insertion
时间窗: Intraoperative
The primary efficacy endpoint will compare the maximum depth of enteroscope insertion for the study device to the maximum depth of enteroscope insertion data reported in medical literature for the Spirus Medical Endo-Ease Discovery™ SB overtube.
次要结局
- Total procedure time(Intraoperative)
- Insertion time(Intraoperative)
- Withdrawn time(Intraoperative)
- Total enteroscopy rate(Intraoperative)
- Diagnostic yield(Intraoperative)
- Adverse events(7 days post-procedure)
- Device deficiencies(Intraoperative)