Trials / Unknown
UnknownNCT03423485
Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.
A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety and Performance Profile of the CG-100 Intraluminal Bypass Device in Patients Undergoing Colorectal Surgery
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 137 (estimated)
- Sponsor
- Colospan Ltd. · Industry
- Sex
- All
- Age
- 22 Years – 75 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)
Detailed description
Colospan is initiating a pivotal clinical prospective, multi-center, single-arm, open-label study designed to evaluate safety and performance profile of the CG-100 Intraluminal Bypass Device in patients undergoing colorectal surgery study. Up to 137 patients (in total) will be enrolled in up to 12 sites in Europe, Israel and USA. Study objectives Primary Objective: To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic) Secondary Objectives: To evaluate Performance in terms of clinical and radiological anastomotic leakage Successful positioning and maintenance of device position To assess the ease of the device's application and removal Safety: To assess the safety profile of the CG-100 Intraluminal Bypass Device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CG-100 Intraluminal Bypass Device | Intended to reduce contact of fecal content with an anastomotic site , following colorectal surgery. |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2019-06-01
- Completion
- 2019-07-31
- First posted
- 2018-02-06
- Last updated
- 2018-10-04
Locations
5 sites across 4 countries: France, Germany, Israel, Switzerland
Source: ClinicalTrials.gov record NCT03423485. Inclusion in this directory is not an endorsement.