NCT02841891终止不适用
A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 58
- 试验地点
- 32
- 主要终点
- Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications
研究概览
简要总结
The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 22 years of age or older
- •Be scheduled for a colectomy procedure with a stapled anastomosis
- •At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (≥90%)
- •Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
- •Agree to return for all follow-up evaluations and procedures specified in the protocol
- •Understand and give informed consent
排除标准
- •Albumin < 3 g/dL
- •ASA score (American Society of Anesthesiologists) ≥ 4
- •Neutropenia ≤ 800 cells/µl
- •Pregnant at time of surgery
- •Has AIDS (HIV positive not excluded)
- •Has neutropenia (IBD and steroid use not excluded)
- •Has a known blood clotting disorder requiring treatment
- •Has any condition known to effect wound healing, such as collagen vascular disease
- •Has known or suspected allergy or sensitivity to any test materials, reagents, or WCE contrast materials
- •Has undergone chemotherapy within 4 weeks of the anastomosis procedure and/or radiation within 3 days of the anastomosis procedure
- •Concurrently using fibrin sealants or other anastomosis care devices
- •Emergency surgery for abdominal indications
- •Has undergone a colectomy procedure in the previous two months
- •Has an emergent infection related to a previous colectomy procedure
- •Is scheduled to undergo a Hartmann's procedure
- •Is scheduled to undergo trans-anal endoscopic microsurgery (TEM)
- •Is scheduled to undergo procedure using omental wrapping
- •Is participating in another medical device trial involving colectomy with anastomosis
- •First 20 subjects ONLY:
- •Is diagnosed with high risk cancer as determined by preoperative clinical evidence or diagnostic imaging (if patient's cancer stage has been downstaged through treatment prior to baseline screening, subject is allowed to be included):
- •Lymph Node Cancer Stage: N2
- •Cancer Tumor Size: T4
- •Circumferential resection margin: CRM+ (Positive)
研究组 & 干预措施
Test
Experimental
Test group will receive Sylys® Surgical Sealant as an adjunct to standard closure of stapled anastomosis in colectomy procedure.
干预措施: Sylys® Surgical Sealant (Device)
Control
Active Comparator
Control group will receive standard of care closure of stapled anastomosis in colectomy procedure without Sylys® Surgical Sealant.
干预措施: Stapled Anastomosis Colectomy Procedure (Procedure)
结局指标
主要结局
Safety of Sylys® Surgical Sealant: Number of Anastomosis-Related Complications
时间窗: 26 Weeks
Number of subjects with anastomosis-related complications
次要结局
- Reduction in Anastomotic Leaks(26 Weeks)
- Sealant Application Evaluation Questionnaire(At time of device application (during surgery))
研究者
研究点 (32)
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