SafeHeal Diverting Ileostomy Pivotal Study (NCT06152276) | Clinical Trial Compass
CompletedNot Applicable
SafeHeal Diverting Ileostomy Pivotal Study
United States132 participantsStarted 2024-01-01
Plain-language summary
This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult patients (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 ≤ 2
✓. Willingness 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 System (not applicable for control cohort)
✕. 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