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)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
137
Intended to reduce contact of fecal content with an anastomotic site , following colorectal surgery.
Hospital Beaujon
Paris, Clichy, France
RECRUITINGUniversity Hospital of Hamburg
Hamburg, Germany
RECRUITINGSoroka Medical Center
Beersheba, Israel
RECRUITINGTo 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)
Leak proof seal with at least 85% success at balloon-Mucosa interface as evidenced by contrast through the device lumen without extravasation and no illumination of the anastomosis.
Time frame: device removal day (10 days +/-1)
To assess the safety profile of the CG-100 Intraluminal Bypass Device.
Rate of adverse events
Time frame: During surgical procedure and up to 30 days (+/- 5) ]
To evaluate Performance in terms of clinical anastomotic leakage based on clinical symptoms of the patient such as fever, blood tests.
The patient will be followed for 10±1 days to assess the occurrence of clinical anastomotic leakage based on positive clinical symptoms of the patient such as fever, blood tests, while the CG-100 Intraluminal Bypass Device is in situ. In addition, at 10±1 days a rectal contrast enema will be done to assess the occurrence of radiological anastomotic leakage.
Time frame: Device deployment until device removal day (10 days +/-1)
Successful positioning and maintenance of device position
Position of internal sheath during rectal contrast enema based on radiological demonstration
Time frame: 10+1 days post-surgery before device removal
To assess the ease of the device's application and removal
Assessment of the ease of the device's application will be done using a Device application use questionnaire completed by the surgeon at Procedure Day. The ease of device removal will also be assessed on Discharge Day, using the Device application use questionnaire
Time frame: Surgical procedure and Device removal day (10 days +/-1)
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Carmel Medical Center
Haifa, Israel
RECRUITINGCHUV, University Hospital Vaudois
Lausanne, Switzerland
RECRUITINGTo assess the safety profile of the CG-100 Intraluminal Bypass Device.
Rate of device related complications
Time frame: Up to 30 (+/- 5) days
To assess the occurrence of radiological anastomotic leakage, evaluated by performing a rectal contrast enema .
At 10±1 days a rectal contrast enema will be done to assess the occurrence of radiological anastomotic leakage.
Time frame: At 10±1 days