Trials / Completed
CompletedNCT02109991
Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Colospan Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CG-100 device | Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2017-10-01
- Completion
- 2017-10-01
- First posted
- 2014-04-10
- Last updated
- 2017-12-08
Locations
8 sites across 4 countries: Belgium, Croatia, Hungary, Israel
Source: ClinicalTrials.gov record NCT02109991. Inclusion in this directory is not an endorsement.