A Prospective, Multi-center, Open Label, Non-randomized Study, of Seal-G Surgical Sealant for the Reinforcement of Gastrointestinal Anastomosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Rate of device related complications
研究概览
简要总结
The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for the reinforcement and protection of gastrointestinal anastomosis.
详细描述
Pre-Surgery:
Screening will be performed among adult subjects who are scheduled for an elective colorectal surgery. Pre-surgery assessments (after completion of consent process and signed ICF) will be according to the routine practice.
Intra-operative:
During surgery, an assessment of the intra-operative exclusion criteria will be performed. If the subject does not meet any of the exclusion criteria, the subject will be further enrolled. Surgery will be performed according to the site standard of care (routine practice). Anastomosis will be created either using a stapler device (linear or circular), according to manufacture IFU (Instructions for use) or hand suture according to surgeon best practice technique. Once anastomosis has been created, surgeon will verify the anastomosis and mucosal donuts integrity.
Device (Seal-G) application on anastomotic site
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
- •Subject is ≥ 18 years old.
- •Subject is planned to undergo an elective open or laparoscopic colonic resection with the creation of an anastomosis (extracorporeal if laparoscopic surgery is performed).
- •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.
排除标准
- •Subject, undergoing low anterior resection
- •Subject is planned to undergo an emergency procedure
- •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, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection)
- •Subject who according to the investigator clinical judgement is at risk for anastomosis dehiscence
- •Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days
- •Subject's ASA (American Society of Anesthesiology) score ≥ 4
- •Subject's BMI > 34 or <16
- •Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)
- •Subject with a life expectancy of less than 1 year
- •Subject requires more than one anastomosis during the surgery
- •Woman who is known to be pregnant
- •Mentally handicapped, prisoners, or legally incompetent
- •Intraoperative Exclusion Criteria:
- •Subjects whom anastomosis is less than 10 cm from the anal verge
- •The full circumference of the anastomosis is not accessible for Seal-G application
- •Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G
- •Subject has excessive intraoperative bleeding prior to the anastomosis formation as assessed by the investigator (estimated in excess of 500mL)
- •Subject has peritoneal carcinomatosis
结局指标
主要结局
Rate of device related complications
时间窗: Postoperative to end of follow up (30±7 days)
次要结局
- Overall rate of complications(Postoperative to end of follow up (30±7 days))
- Postoperative length of hospitalization stay(Postoperative till time for "ready to be discharged" (10±4 days))
- Duration of sealant application(Intraoperative: starting from initial spreading on the treatment site to completion of curing, will be recorded (in minutes))
- Ease of use of the device(Intraoperative: device application)