A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety and Performance Profile of the CG-100 Intraluminal Bypass Device in Patients Undergoing Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic)
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)
详细描述
Colospan is initiating a pivotal clinical prospective, multi-center, single-arm, open-label study designed to evaluate safety and performance profile of the CG-100 Intraluminal Bypass Device in patients undergoing colorectal surgery study.
Up to 137 patients (in total) will be enrolled in up to 12 sites in Europe, Israel and USA.
Study objectives Primary Objective: To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic) Secondary Objectives: To evaluate Performance in terms of clinical and radiological anastomotic leakage Successful positioning and maintenance of device position To assess the ease of the device's application and removal Safety: To assess the safety profile of the CG-100 Intraluminal Bypass Device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is willing to comply with protocol-specified follow-up evaluations
- •Patient 22-75 years of age at screening
- •The patient is scheduled to undergo an elective colorectal surgery (open, laparoscopic, or robotic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
- •The patient or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).
排除标准
- •Preoperative
- •Pregnant or nursing female subjects. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.
- •Patient surgical treatment is acute (not elective)
- •Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
- •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 classification > 3
- •Albumin < 30 g/liter
- •Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
- •Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery.
- •Patient is participating in another clinical trial within 30 days of screening
- •Patient has been taking regular steroid medication in the last 6 months.
- •Patient has contraindications to general anesthesia
- •Patient has preexisting sphincter problems
- •Patient has evidence of extensive local disease in the pelvis
- •Any condition which in the opinion of the investigator may jeopardize the patient's safe participation Intraoperative (prior to device deployment)
- •Anastomosis is located more than 20 cm from the anal verge
- •Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm
- •Blood loss (> 500 cc)
- •Anastomosis was not performed for any reason other than consequences as a result of use of the study device -
研究组 & 干预措施
Study arm
Anastomosis is performed according to Standard of Care with the addition of the CG-100 Intraluminal Bypass Device
干预措施: CG-100 Intraluminal Bypass Device (Device)
结局指标
主要结局
To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic)
时间窗: device removal day (10 days +/-1)
Leak proof seal with at least 85% success at balloon-Mucosa interface as evidenced by contrast through the device lumen without extravasation and no illumination of the anastomosis.
次要结局
- To assess the safety profile of the CG-100 Intraluminal Bypass Device.(Up to 30 (+/- 5) days)
- To evaluate Performance in terms of clinical anastomotic leakage based on clinical symptoms of the patient such as fever, blood tests.(Device deployment until device removal day (10 days +/-1))
- Successful positioning and maintenance of device position(10+1 days post-surgery before device removal)
- To assess the ease of the device's application and removal(Surgical procedure and Device removal day (10 days +/-1))
- To assess the occurrence of radiological anastomotic leakage, evaluated by performing a rectal contrast enema .(At 10±1 days)