A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant

Not Applicable

Terminated

• Conditions: Colorectal and Ileorectal Anastomosis
• Interventions: Device: Test- Treatment with Sylys Surgical Sealan

• Registration Number: NCT02960139
• Lead Sponsor: Cohera Medical, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-09
• Study Start: 2017-04-13
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• 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

Exclusion Criteria

• Albumin < 3
• ASA ≥ 4
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test- Treatment with Sylys Surgical Sealant	Test- Treatment with Sylys Surgical Sealan	Standard closure plus treatment with Sylys Surgical Sealant

Primary Outcome Measures

Name	Time	Method
A comparison of the incidence of anastomosis-related complications	from day of surgery to week 26

Secondary Outcome Measures

Name	Time	Method
A comparison of the proportion of patients who have incidence of sub-clinical or clinical anastomotic leaks	14 days, 12 weeks, 26 weeks	A comparison of the proportion of patients who have either sub-clinical or clinical anastomotic leaks in each group.

Trial Locations

Locations (6)

OLVG; 🇳🇱 Amsterdam, Netherlands

Laurentius; 🇳🇱 Roermond, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

Flevoziekenhuis; 🇳🇱 Almere, Flevoland, Netherlands

Meander Medical Center; 🇳🇱 Amersfoort, Netherlands

AMC; 🇳🇱 Amsterdam-Zuidoost, Netherlands