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SafeHeal Diverting Ileostomy Pivotal Study

NCT06152276 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Diverting loop ileostomy

Diverting loop ileostomy following low anterior resection of colorectal cancer

Sponsors & Collaborators

  • SafeHeal Inc

    lead INDUSTRY

Principal Investigators

  • Patricia Sylla, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-01-30
Completion
2026-01-30

Countries

  • United States
  • Belgium
  • France
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06152276 on ClinicalTrials.gov