Safety, Tolerability and Performance Profile of the Colospan Device 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).

Official Title
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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

Conditions
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Gastrointestinal Anastomosis

Intervention / Treatment
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* Device: CG-100 device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is scheduled to undergo an elective colorectal surgery (open or laparoscopic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge The patient is willing to comply with protocol-specified follow-up evaluations The patient signed Informed Consent Exclusion Criteria: Pregnant or nursing female subjects Patient surgical treatment is acute (not elective) Patient has infections at the time of intervention 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 (American Society of Anesthesiologists) classification > 3 diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease Patient is participating in another clinical trial within 30 days of screening Patient has been taking regular steroid medication in the last 6 months Contraindications to general anesthesia Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm Blood loss (> 500 cc) Leak test failure during surgery Any condition or surgical incidence where the device deployment can jeopardize the patient's safety or interferes with study outcome per the discretion of the investigator

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CG-100 device<br> | Device: CG-100 device<br>* Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events, and device related complications |  | During surgical procedure and up to 30 days (+/- 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of anastomotic leakage when the CG-100 is used |  | Up until device removal day (10 days +/-1) | 
| Position of the device (internal sheath) |  | Device removal day (10 days +/-1) | 
| Assessment of the device's application technique ease of placement and extraction of the device performance |  | Device removal day (10 days +/-1) | 
| Determine subject tolerability of the device |  | Device removal day (10 days +/- 1) |