NCT02109991已完成不适用
A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 16
- 主要终点
- Rate of adverse events, and device related complications
研究概览
简要总结
The purpose of this study is to evaluate the CG-100 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is scheduled to undergo an elective colorectal surgery (open or laparoscopic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
- •The patient is willing to comply with protocol-specified follow-up evaluations
- •The patient signed Informed Consent
排除标准
- •Pregnant or nursing female subjects
- •Patient surgical treatment is acute (not elective)
- •Patient has 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
- •Patients with ASA (American Society of Anesthesiologists) classification > 3
- •diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
- •Patient is participating in another clinical trial within 30 days of screening
- •Patient has been taking regular steroid medication in the last 6 months
- •Contraindications to general anesthesia
- •Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis
- •Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm
- •Blood loss (> 500 cc)
- •Leak test failure during surgery
- •Any condition or surgical incidence where the device deployment can jeopardize the patient's safety or interferes with study outcome per the discretion of the investigator
研究组 & 干预措施
CG-100 device
Experimental
干预措施: CG-100 device (Device)
结局指标
主要结局
Rate of adverse events, and device related complications
时间窗: During surgical procedure and up to 30 days (+/- 5)
次要结局
- Occurrence of anastomotic leakage when the CG-100 is used(Up until device removal day (10 days +/-1))
- Position of the device (internal sheath)(Device removal day (10 days +/-1))
- Determine subject tolerability of the device(Device removal day (10 days +/- 1))
- Assessment of the device's application technique ease of placement and extraction of the device performance(Device removal day (10 days +/-1))
研究者
研究点 (16)
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