NCT03352570已完成不适用
Safe (Safe Anastomosis Feasibility Evaluation)-1 Study : a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac Colorectal Anastomosis Protection Device First-In-man Clinical Investigation Study
Safeheal6 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2017年11月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Rate of adverse events
研究概览
简要总结
The purpose of this study is to evaluate theColovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- 否
入选标准
- •Subject must be >= 18 and <= 65 years old
- •Indicated for colorectal resection
- •Patient has been assessed by a multi-disciplinary team and it was determined that as per standard of care, they are eligible to bear a diverting ostomy
- •Willing to comply with protocol-specified follow-up evaluations
- •Signed Informed Consent
排除标准
- •Patient with inflammatory bowel disease
- •Pregnant or nursing female subject (a pregnancy test should be conducted the day prior to the procedure for all women in age of procreating)
- •Known allergy to nickel or other components of the Colovac kit
- •Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including:
- •immunodeficiency
- •steroid therapy
- •infections at the time of intervention
- •major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
- •diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis
- •preexisting sphincter problems or evidence of extensive local disease in the pelvis
- •blood loss (> 500 cc)
- •non amended peroperative anastomosis failure
- •intra-operative adverse events
- •malnourishment
- •obesity (BMI > 35)
- •history of excessive smoking and alcohol use
- •The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
- •Patient unable to give consent
研究组 & 干预措施
COLOVAC device
Experimental
colorectal surgery performed per standard of care with deployment of the Colovac device to protect the anastomosis site
干预措施: COLOVAC (Device)
结局指标
主要结局
Rate of adverse events
时间窗: up to 3 months
occurence of intraoperative and postoperative complications
次要结局
- level of patient comfort measured using NIH's PROMIS health measurement questionnaires(up to 15 days after surgery)
- occurence of anastomosis leakage(up to 3 months after initial surgery)
- occurrence of anastomosis fistula(up to 3 months after initial surgery)
- Colovac procedure time(During surgery)
- Migration rate of the Colovac device(During surgical procedure and up to 15 days after placement)
- rate of digestive disorders(up to 15 days after surgery)
- device introduction success rate(During surgery)
- occurrence of anastomotic abcesses(up to 3 months after initial surgery)
- Device placement success rate(During surgery)
- Device retrieval success rate(At 14 days after device placement)
研究者
研究点 (6)
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