Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501105
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Performance of WOUNDCHEK Bacterial Status
Sponsor:
Woundchek Laboratories BV
Organization:
Woundchek Laboratories BV
Study Overview
Official Title:
Clinical Study to Evaluate the Performance of WOUNDCHEK Bacterial Status
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical study is to evaluate the performance of WOUNDCHEK Bacterial Status WCBS when the test result is used to inform treatment decisions
Detailed Description:
The clinician treating the wound will be allowed to use the test result in treatment decisions The pretest treatment plan will be documented on the Case Report Form CRF prior to performing the WCBS test After receiving the test result the clinician will document the post-test treatment plan The healing outcome at 12 weeks following the test will be recorded on the CRF The study will evaluate the healing outcomes compared to when test results are not used to assist in treatment decisions with study success defined as a higher healing rate andor mean wound size reduction for WCBS positive wounds than obtained in the study PROT-2023-001 Also the healing rate of wounds with a negative test result will be compared to the pretest rate to ensure that clinicians do not neglect and under treat this cohort with success criteria being that the WCBS negative wound healing rate is not worse than the pre-test healing rate Additionally the study will establish whether there are any device related Serious Adverse Events SAEs or Unanticipated Adverse Device Effects UADEs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None