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 anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2History of left sided colitis
• Willingness to comply with protocol-specific treatment and study visits and to sign a 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 the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo protocol described procedures or interfere with the interpretation of study results including, but not limited to:
• Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
• Immunodeficiency (CD4+ count 750 cc)
• Blood transfusion
• Any new sign of ischemia
• Positive air leak test
• Inadequate bowel preparation
• Anastomosis location greater than 15 cm from the anal verge
• Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device