SafeHeal Diverting Ileostomy Pivotal Study — SH-SOC23  

Colorectal Cancer Clinical Trial

Official title: SafeHeal Diverting Ileostomy Pivotal Study (SH-SOC23)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Stoma Ileostomy

• NCT number: NCT06152276
• Study type: Interventional
• Source: SafeHeal Inc
• Contact: Marci Halevi
• Phone: 929-541-6935
• Email: mhalevi@safeheal.com
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: December 1, 2025