Seal-G and Seal-G MIST Study for Reinforcement and Protection of Colonic Anastomoses in Subjects Undergoing Colonic Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Proportion of surgeries with full sealant coverage - successful application
研究概览
简要总结
A prospective, multi-center, open label, study to evaluate safety and performance of Seal-G and Seal-G MIST in reinforcing colonic anastomosis, in subjects undergoing Colon Resection surgery
详细描述
Seal-G and Seal-G MIST Surgical Sealants are intended for the reinforcement and protection of gastrointestinal anastomosis. The Seal-G and Seal-G MIST devices share the same Alginate based sealant technology and intended purpose. The devices only differ in their method of application, The Seal-G device is designed for spread application by extra-corporal approach, and the Seal-G MIST device is designed for spray application by intra-corporal approach.
The proposed Clinical Investigation aims to collect clinical evidence on the devices' usage, including safety, performance and usability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject signs and dates a written ICF, indicates an understanding of the study procedures and follow-up requirements and is willing to comply with them.
- •Subject is aged 18 years to 80 years
- •Subject is scheduled for elective open or laparoscopic (including robotic) colon cancer resection surgery with primary anastomosis (excluding low anterior resection)
排除标准
- •Anastomosis is expected to be ≤ 10cm from anal verge
- •Surgery involves stoma creation
- •Subject who underwent a prior pelvic radiation therapy
- •Subject with a BMI > 40 or <19
- •Subject with ASA status higher than 3
- •Albumin level < 3 gr/dl
- •Total bilirubin >1.5 mg/dL
- •Hemoglobin level < 8mg/dl on day of surgery
- •Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis
- •Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids)
- •Serious or uncontrolled co-existent diseases (e.g. severe cardiovascular disease, congestive heart failure, recent myocardial infarction within 6 months from surgery, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection, uncontrolled DM with episodes of hospitalization due to hypo or hyperglycemia within 6 months of surgery)
- •Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)
- •Subject with known sensitivity to Indigo carmine dye (FD&C 2/ E132)
- •Subject who according to the investigator clinical judgement is not suitable for participation in the study or is at risk
- •Subject requires more than one anastomosis during the surgery
- •Subject is scheduled for another surgery during the follow up period of this study
- •Subjects who cannot comply with study visits/ procedures or have poor compliance (e.g. mentally handicapped, prisoners, etc.)
- •Intraoperative Exclusion Criteria:
- •Subjects who meet any of the following intra-operative exclusion criteria will be considered as screen failures and will not be eligible for the study:
- •Positive leak test requires anastomosis takedown and/or re-anastomosis.
- •Additional resection (not including tissue biopsy) of non-colonic solid organ (e.g. Liver resection, uterus, bladder, seminal vesicle, ureter)
- •Subjects whom anastomosis is ≤10 cm from the anal verge
- •Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G/Seal-G MIST
- •Subject received two or more units of PC transfusion during surgery
- •Subject has peritoneal carcinomatosis or any other metastasis observed by the surgeon
结局指标
主要结局
Proportion of surgeries with full sealant coverage - successful application
时间窗: At time of surgery
1- The surgeon applied the sealant over the full circumference of the anastomosis (successful application). 0 - The surgeon did not fully cover the anastomosis circumference
次要结局
- Proportion of subjects with subclinical / radiological leaks(Up to 30 days post-surgery)
- Proportion of subjects with clinical anastomotic leaks(Up to 30 days post-surgery)
- Proportion of subjects with at least one Serious Adverse Event(Up to 30 days post-surgery)
- Proportion of subjects that had a reoperation(Up to 30 days post-surgery)
- Hospital length of stay(Up to 30 days post-surgery)