SafeHeal Diverting Ileostomy Pivotal Study

Inclusion Criteria:

1. Adult patients (18 years of age or older)

2. Eligible to undergo open or minimally invasive sphincter-sparing low anteriorresection with planned diverting loop ileostomy for malignancy, based onmultidisciplinary team recommendations.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

4. Willingness to comply with protocol-specific treatment and study visits and to signa written Informed Consent Form

Exclusion Criteria:

Preoperative

1. History of left colitis

2. Known allergy to nickel or other components of the Colovac System (not applicablefor control cohort)

3. Pregnant or nursing female subject

4. Concomitant major surgical procedure in combination with Colorectal resection (i.e.,hepatectomy)

5. Any serious or uncontrolled medical disorder that, in the opinion of theinvestigator, may increase the risk associated with study participation, impair theability of the participant to undergo protocol described procedures or interferewith the interpretation of study results including, but not limited to:

6. Stage IV colorectal cancer unless curative intent R0 resection is planned ANDthere is no associated peritoneal disease

7. Immunodeficiency (CD4+ count < 500 CU MM)

8. Systemic steroid therapy within the past 6 months

9. Systemic infection at the time of surgery or requiring systemic antimicrobialtherapy up to 1 week before surgery

10. Major surgical or interventional procedures within 30 days prior to this studyor planned surgical or interventional procedures within 30 days of entry intothis study

11. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowelperforation, intraabdominal infection, ischemic bowel, or carcinomatosis

12. Fecal incontinence, involvement of sphincter by the neoplastic disease orevidence of extensive local disease in the pelvis seen on pre-operative imaging

13. Severe malnutrition defined as 10% weight loss within 3 months prior toenrollment.

14. The subject is currently participating in another investigational drug or devicestudy Intraoperatively:

15. Occurrence of any of the following during the colorectal surgery:

16. Blood loss (>750 cc)

17. Blood transfusion

18. Any new sign of bowel ischemia

19. Positive air leak test

20. Inadequate bowel preparation

21. Anastomosis location greater than 10 cm from the anal verge

22. Any other surgical complications or intra-operative risks that may place thepatient at greater risk from study procedures