SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study

Inclusion Criteria:

• 18 years of age or older

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

• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2History of leftsided colitis

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

Exclusion Criteria:

• History of left sided colitis

• Known allergy to nickel or other components of the Colovac 2 System

• Pregnant or nursing female subject

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

• 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:

• Stage IV colorectal cancer unless curative intent R0 resection is planned AND thereis no associated peritoneal disease

• Immunodeficiency (CD4+ count < 500 CU MM)

• Systemic steroid therapy within the past 6 months

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

• Major surgical or interventional procedures within 30 days prior to this study orplanned surgical or interventional procedures within 30 days of entry into thisstudy

• Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation,intraabdominal infection, ischemic bowel, carcinomatosis

• Fecal incontinence, involvement of sphincter by the neoplastic disease or evidenceof extensive local disease in the pelvis seen on pre-operative imaging

• Severe malnutrition which is defined as at least 10% weight loss within 3 monthsprior to enrollment.

• Occurrence of any of the following during the colorectal surgery:

1. Blood loss (>750 cc)

2. Blood transfusion

3. Any new sign of ischemia

4. Positive air leak test

5. Inadequate bowel preparation

6. Anastomosis location greater than 15 cm from the anal verge

7. Other intra-operative risks that preclude the subject from undergoing theprocedure with the investigational device