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NCT06560125 · ClinicalTrials.gov registry record
WOUNDCHEK Bacterial Status Performance With Trained vs Untrained Users
A clinical trial, sponsored by Woundchek Laboratories.
- Completed
- Registry status
- 36
- Enrollment target
NCT06560125 is a clinical trial that has completed, run by Woundchek Laboratories. The registered enrollment target is 36 participants.
The verdict
NCT06560125 has completed, sponsored by Woundchek Laboratories.
- COMPLETED
- Registry status
- 36 participants
- Enrollment target
Study Summary
The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) with untrained users in diverse CLIA waived locations and trained users and compare the results to those obtained in the study used for De Novo approval (DEN180014). Untrained and trained users are as defined in the FDA guidance document entitled 'Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices' (Feb 2020). The test result will be blinded to the clinician treating the wound. The healing outcome at 12 weeks following the test will be compared for wounds positive vs negative for bacterial protease activity (BPA). Study success criteria will be that the positive likelihood ratio (PLR) of a BPA positive wound being non-healing at 12 weeks for both trained and untrained users will be statistically comparable to the PLR obtained in the study submitted for DEN180014.
Interventions
- OTHER Standard care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2025-02-14 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06560125
The ClinicalTrials.gov registry entry for NCT06560125 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Woundchek Laboratories, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Standard care is the first listed.
NCT06560125 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06560125 about?
NCT06560125 is a clinical study titled "WOUNDCHEK Bacterial Status Performance With Trained vs Untrained Users". The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) with untrained users in diverse CLIA waived locations and trained users and compare the results to those obtained in the study used for De Novo approval (DEN180014). Untrained and trained users ar...
What is the current status of trial NCT06560125?
This trial is currently completed. The enrollment target is 36 participants. The study started on 2024-08-01. Estimated completion is 2025-02-14.
What interventions are being tested in trial NCT06560125?
The interventions under investigation include: Standard care (OTHER).
Who is sponsoring clinical trial NCT06560125?
This trial is sponsored by Woundchek Laboratories, which has 2 total clinical trials registered on ClinicalTrials.gov.
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