Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Device: CG-100 Intraluminal Bypass Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is willing to comply with protocol-specified follow-up evaluations Patient 22-75 years of age at screening The patient is scheduled to undergo an elective colorectal surgery (open, laparoscopic, or robotic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge The patient or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB). Exclusion Criteria: Preoperative Pregnant or nursing female subjects. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test. Patient surgical treatment is acute (not elective) Patient has local or systemic infection at the time of intervention (e.g., peritonitis) Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study Patients with ASA classification > 3 Albumin < 30 g/liter Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease BMI ≥ 40 Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery. Patient is participating in another clinical trial within 30 days of screening Patient has been taking regular steroid medication in the last 6 months. Patient has contraindications to general anesthesia Patient has preexisting sphincter problems Patient has evidence of extensive local disease in the pelvis Any condition which in the opinion of the investigator may jeopardize the patient's safe participation Intraoperative (prior to device deployment) Anastomosis is located more than 20 cm from the anal verge Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm Blood loss (> 500 cc) Anastomosis was not performed for any reason other than consequences as a result of use of the study device -

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Anastomosis is performed according to Standard of Care with the addition of the CG-100 Intraluminal Bypass Device | Device: CG-100 Intraluminal Bypass Device<br>* Intended to reduce contact of fecal content with an anastomotic site , following colorectal surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | device removal day (10 days +/-1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety profile of the CG-100 Intraluminal Bypass Device. | Rate of adverse events | 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. | 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 | 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 | Surgical procedure and Device removal day (10 days +/-1) | 
| To assess the safety profile of the CG-100 Intraluminal Bypass Device. | Rate of device related complications | 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. | At 10±1 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Surgery