a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device.

Safe (Safe Anastomosis Feasibility Evaluation)-1 Study : a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac Colorectal Anastomosis Protection Device First-In-man Clinical Investigation Study

The purpose of this study is to evaluate theColovac 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:

1. Subject must be >= 18 and <= 65 years old
2. Indicated for colorectal resection
3. Patient has been assessed by a multi-disciplinary team and it was determined that as per standard of care, they are eligible to bear a diverting ostomy
4. Willing to comply with protocol-specified follow-up evaluations
5. Signed Informed Consent

Exclusion Criteria:

1. Patient with inflammatory bowel disease

2. Pregnant or nursing female subject (a pregnancy test should be conducted the day prior to the procedure for all women in age of procreating)

3. Known allergy to nickel or other components of the Colovac kit

4. Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including:

   1. immunodeficiency
   2. steroid therapy
   3. infections at the time of intervention
   4. 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
   5. diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis
   6. preexisting sphincter problems or evidence of extensive local disease in the pelvis
   7. blood loss (> 500 cc)
   8. non amended peroperative anastomosis failure
   9. intra-operative adverse events
   10. malnourishment
   11. obesity (BMI > 35)
   12. history of excessive smoking and alcohol use

5. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study

6. Patient unable to give consent