NCT06152276

SafeHeal Diverting Ileostomy Pivotal Study

SafeHeal Diverting Ileostomy Pivotal Study (SH-SOC23)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: SafeHeal Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The data from this study could serve as the historical control arm data of a SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-3) Pivotal Study designed as a prospective, non-randomized, sequential, controlled, multicenter trial comparing the investigational device, the next generation Colovac Anastomosis Protection Device, to the standard of care (SOC), diverting ostomy.

Conditions

• Colorectal Cancer
• Stoma Ileostomy

Interventions

Type	Name	Description
OTHER	Diverting loop ileostomy	Diverting loop ileostomy following low anterior resection of colorectal cancer

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-02-28
• Completion: 2026-03-01
• First posted: 2023-11-30
• Last updated: 2026-02-18

Locations

3 sites across 1 country: United States