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

A Pivotal, Prospective, Randomized, Controlled, Multicenter Superiority Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Technique Plus Sylys® Surgical Sealant

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal and Ileorectal Anastomosis
• Intervention / Treatment: Device: Test- Treatment with Sylys Surgical Sealan

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amersfoort, Netherlands
    • Meander Medical Center
  • Amsterdam, Netherlands
    • OLVG
  • Amsterdam-Zuidoost, Netherlands
    • AMC
  • Roermond, Netherlands
    • Laurentius
  • Utrecht, Netherlands
    • Diakonessenhuis
  • Flevoland
    • Almere, Flevoland, Netherlands
      • Flevoziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test- Treatment with Sylys Surgical Sealant; Standard closure plus treatment with Sylys Surgical Sealant	Device: Test- Treatment with Sylys Surgical Sealan; Standard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant
No Intervention: Control- Standard of Care; Control group is standard closure of anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A comparison of the incidence of anastomosis-related complications	from day of surgery to week 26

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cohera Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PRO-106-0119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No