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NCT05010850 · ClinicalTrials.gov registry record · NA
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
A NA study, sponsored by SafeHeal.
- Terminated
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT05010850: Clinical Trial NA study, sponsored by SafeHeal.
NCT05010850 is a NA study that was terminated before completion, run by SafeHeal. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05010850, a NA study, was terminated before completion, sponsored by SafeHeal.
- TERMINATED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
Primary Outcome
Reduction in stoma creation rate
Interventions
- DEVICE Colovac
- PROCEDURE Stoma Creation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-01-17 |
| Est. Completion | 2024-01-19 |
| Phase | NA |
Why NCT05010850 stopped before completion
NCT05010850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Colovac is the first listed.
NCT05010850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05010850 about?
NCT05010850 is a clinical study titled "SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study". A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
What is the current status of trial NCT05010850?
This trial is currently terminated. It is a NA study. The enrollment target is 18 participants. The study started on 2022-01-17. Estimated completion is 2024-01-19.
What interventions are being tested in trial NCT05010850?
The interventions under investigation include: Colovac (DEVICE), Stoma Creation (PROCEDURE).
Who is sponsoring clinical trial NCT05010850?
This trial is sponsored by SafeHeal, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05010850's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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