Trials / Terminated
TerminatedNCT02841891
A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
A Prospective, Randomized, Controlled, Multicenter Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Cohera Medical, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.
Conditions
- Colorectal and Ileorectal Anastomosis
- Colocolic and Ileocolic Anastomosis
- Coloanal and Ileoanal Anastomosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sylys® Surgical Sealant | Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant |
| PROCEDURE | Stapled Anastomosis Colectomy Procedure | Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2018-08-13
- Completion
- 2018-08-13
- First posted
- 2016-07-22
- Last updated
- 2018-08-16
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02841891. Inclusion in this directory is not an endorsement.