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NCT06152276 · ClinicalTrials.gov registry record
SafeHeal Diverting Ileostomy Pivotal Study
A clinical trial of Colorectal Cancer and Stoma Ileostomy, sponsored by SafeHeal.
- Active
- Registry status
- 132
- Enrollment target
- 3
- Study locations
NCT06152276: Active study of Colorectal Cancer and Stoma Ileostomy, sponsored by SafeHeal.
NCT06152276 is a study of Colorectal Cancer and Stoma Ileostomy that is active but no longer recruiting, run by SafeHeal. The registered enrollment target is 132 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06152276, a study of Colorectal Cancer and Stoma Ileostomy, is active but no longer recruiting, sponsored by SafeHeal.
- ACTIVE NOT RECRUITING
- Registry status
- 132 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Early anastomotic complications
Conditions Studied
Interventions
- OTHER Diverting loop ileostomy
Study Locations (3)
New York
- Maimonides Medical Center - Brooklyn
- Lenox Hill Hospital - New York
Massachusetts
- UMass Memorial Medical Center - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2026-03 |
What the registry record for NCT06152276 still lists
NCT06152276 is an observational study that tracks outcomes without assigning an intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Diverting loop ileostomy is the first listed.
NCT06152276 reports a single indexed study location in New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06152276 about?
NCT06152276 is a clinical study titled "SafeHeal Diverting Ileostomy Pivotal Study". 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 endpoi...
What is the current status of trial NCT06152276?
This trial is currently active not recruiting. The enrollment target is 132 participants. The study started on 2024-01-01. Estimated completion is 2026-03.
What conditions does trial NCT06152276 study?
This clinical trial studies the following conditions: Colorectal Cancer, Stoma Ileostomy.
What interventions are being tested in trial NCT06152276?
The interventions under investigation include: Diverting loop ileostomy (OTHER).
Who is sponsoring clinical trial NCT06152276?
This trial is sponsored by SafeHeal, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06152276 being conducted?
This trial has 3 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06152276's enrollment target sits among peer trials
132 191st of 381 higher than 190 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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