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

Colorectal and Ileorectal Anastomosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02960139
• Other study ID #: PRO-106-0119
• Status: Terminated
• Phase: N/A
• Start date: April 13, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: June 2018
• Source: Cohera Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal and Ileorectal Anastomosis

Intervention

Device:
• Test- Treatment with Sylys Surgical Sealan
Standard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant

Locations

Country	Name	City	State
Netherlands	Flevoziekenhuis	Almere	Flevoland
Netherlands	Meander Medical Center	Amersfoort
Netherlands	OLVG	Amsterdam
Netherlands	AMC	Amsterdam-Zuidoost
Netherlands	Laurentius	Roermond
Netherlands	Diakonessenhuis	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Cohera Medical, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A comparison of the incidence of anastomosis-related complications		from day of surgery to week 26
Secondary	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