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

NCT02960139 | Terminated

• 1 other identifier: PRO-106-0119
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 6

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.

Conditions

Colorectal and Ileorectal Anastomosis

Outcome Measures

Primary Outcomes (1)

• A comparison of the incidence of anastomosis-related complications

  from day of surgery to week 26

Secondary Outcomes (1)

• A comparison of the proportion of patients who have incidence of sub-clinical or clinical anastomotic leaks

  14 days, 12 weeks, 26 weeks

Study Arms (2)

Test- Treatment with Sylys Surgical Sealant

EXPERIMENTAL

Standard closure plus treatment with Sylys Surgical Sealant

Device: Test- Treatment with Sylys Surgical Sealan

Control- Standard of Care

NO INTERVENTION

Control group is standard closure of anastomosis.

Interventions

Test- Treatment with Sylys Surgical Sealan DEVICE

Standard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant

Test- Treatment with Sylys Surgical Sealant

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cohera Medical, Inc.: lead

Study Sites (6)

Flevoziekenhuis

Almere Stad, Flevoland, Netherlands

Location

Meander Medical Center

Amersfoort, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

AMC

Amsterdam-Zuidoost, Netherlands

Location

Laurentius

Roermond, Netherlands

Location

Diakonessenhuis

Utrecht, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 9, 2016
• Study Start: April 13, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

NL (6)