SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study

Prior treatment

• Concomitant major surgical procedure in combination with Colorectal resection (i.e., hepatectomy)
• Systemic steroid therapy within the past 6 months
• Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
• 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
• Severe malnutrition which is defined as at least 10% weight loss within 3 months prior to enrollment.
• Occurrence of any of the following during the colorectal surgery:
  • Blood loss (\>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

Other illness

• History of left sided colitis
• Known allergy to nickel or other components of the Colovac 2 System
• 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
• Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
• Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging

Lab values

• Immunodeficiency (CD4+ count \< 500 CU MM)

Other

• Pregnant or nursing female subject

• 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