SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study

SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study: A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device

A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.

A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.

Colovac is a local, temporary, minimally invasive bypass device that provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.

Inclusion Criteria:

1. Adult patients (greater than 18 years of age)
2. Eligible to undergo open or minimally invasive sphincter-preserving lower anterior resection (anastomosis within 10 cm of the anal verge) with planned diverting loop ileostomy for malignant indication, assessed by a multi-disciplinary team.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
4. Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion Criteria:

1. History of left colitis

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

3. Pregnant or nursing female subject

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

5. 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:

   1. COVID-19 positive (active infection) if test required by hospital
   2. Immunodeficiency (CD4+ count < 500 mm3)
   3. Systemic steroid therapy within the past 6 months
   4. Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
   5. 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
   6. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
   7. Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
   8. Severe Malnutrition defined as ≥ 10% weight loss within 3 months prior to enrollment
   9. Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease

6. The subject is currently participating in another investigational drug or device study

7. 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 10 cm from the anal verge
   7. Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device