SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
Stopped: Voluntary and temporary suspension of enrollment.
United States18 participantsStarted 2022-01-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult patients (greater than 18 years of age)
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
✓. Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Exclusion criteria
✕. History of left colitis
✕. Known allergy to nickel or other components of the Colovac kit
✕. Pregnant or nursing female subject
✕. Concomitant major surgical procedure in combination with Colorectal resection (e.g.. 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:
✕. COVID-19 positive (active infection) if test required by hospital