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

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).

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