NCT02960139终止不适用
A Pivotal, Prospective, Randomized, Controlled, Multicenter Superiority Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique 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
- 61
- 试验地点
- 6
- 主要终点
- A comparison of the incidence of anastomosis-related complications
研究概览
简要总结
The Cohera Sylys® Surgical Sealant study is a pivotal, prospective, randomized, controlled, multicenter superiority clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) during stapled colorectal and ileorectal anastomosis procedures.
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 at least 22 years of age
- •Be scheduled for a stapled colorectal or ileorectal anastomosis procedure with or without diverting stoma
- •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
- •Neutropenia ≤ 800
- •Pregnancy
- •The following conditions involving compromised immune system: AIDS (HIV positive not excluded), neutropenia
- •Known blood clotting disorder requiring treatment
- •Any condition known to effect wound healing, such as collagen vascular disease
- •Have known or suspected allergy or sensitivity to any test materials or reagents
- •Concurrent use of fibrin sealants or other anastomosis care devices
- •Surgery for emergency abdominal indications
- •Has undergone a colorectal anastomosis procedure in the previous two months
- •Has an emergent infection related to a previous colorectal anastomosis procedure
- •Is scheduled to undergo a Hartmann's procedure
- •Is scheduled to undergo trans-anal endoscopic microsurgery (TEM) Is participating in another medical device trial related to colorectal anastomosis
研究组 & 干预措施
Test- Treatment with Sylys Surgical Sealant
Experimental
Standard closure plus treatment with Sylys Surgical Sealant
干预措施: Test- Treatment with Sylys Surgical Sealan (Device)
Control- Standard of Care
No Intervention
Control group is standard closure of anastomosis.
结局指标
主要结局
A comparison of the incidence of anastomosis-related complications
时间窗: from day of surgery to week 26
次要结局
- A comparison of the proportion of patients who have incidence of sub-clinical or clinical anastomotic leaks(14 days, 12 weeks, 26 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
终止
不适用
A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical SealantColorectal and Ileorectal AnastomosisColocolic and Ileocolic AnastomosisColoanal and Ileoanal AnastomosisNCT02841891Cohera Medical, Inc.58
已完成
3 期
ReSure Sealant Pivotal StudyCataract Surgery Incision LeakNCT01498224Ocular Therapeutix, Inc.488
已完成
不适用
Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis ClosureStoma Reversal ProcedureNCT02196519Cohera Medical, Inc.16
Unknown
不适用
Clinical Trial of the WC360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular ProceduresBleedingNCT03234894Wound Care 360, Inc.90
已完成
不适用
To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) SutureWrinkleNCT06404372Sutura Medical Technology LLC57