PRO-106-0129
Research type
Research Study
Full title
A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique (Control) to Standard Closure Techniques Plus Sylys® Surgical Sealant (Test).
IRAS ID
217762
Contact name
T. Pinkney
Contact email
Sponsor organisation
Cohera Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
This study aims to demonstrate that subjects treated with Sylys® Surgical Sealant have fewer anastomosis-related complications after stapled anastomosis in colectomy procedures as compared to subjects receiving standard of care. Therefore, this study design is randomized in which half of the patients will receive standard of care anastomosis closure technique and the other half will be randomized into a group where the standard of care anastomosis closure technique plus Sylys Surgical Sealant will be applied. The study objectives are to evaluate the impact of the use of Sylys on the mean Comprehensive Complication Index (CCI) per group, on the overall number of anastomosis related complications per subject, on the proportion of subjects who have anastomotic leaks (clinical or sub-clinical), on rates of post-operative complications and adverse events, and on the number of patients who proceed to ileostomy reversal and the time to qualify for ileostomy reversal and to document the type and duration of adverse events associated with Sylys. This study will include a total of 730 patients in the US, Europe) and other territories. Sites to be determined.
REC name
Wales REC 6
REC reference
18/WA/0018
Date of REC Opinion
28 Mar 2018
REC opinion
Further Information Favourable Opinion