SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study
United States108 participantsStarted 2026-01-08
Plain-language summary
Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year. The majority of patients receive surgical treatment. Colorectal surgery is associated with a high risk of morbidity and mortality in comparison to other general surgery subspecialties. This study aims to further assess the safety and effectiveness of the Colovac Anastomosis Protection Device, a temporary intraluminal bypass device, on a larger scale.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Adult patients (22 years of age or older)
✓. Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
✓. Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Exclusion criteria
✕. Active colitis
✕. Known allergy to nickel or other components of the Colovac 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:
What they're measuring
1
Performance: Clinically meaningful ostomy avoidance rate at Day 10