N/A
Completed N=60
The Intrepid Clinical Engineering Study
Source: ClinicalTrials.gov NCT05636332 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Validation of Algorithm Software Update — 0; 0; 0 Participants
Summary
The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Validation of Algorithm Software Update |
0; 0; 0 | — |
| PRIMARY Diagnostic Quality |
20; 20; 20 | — |
| SECONDARY Adverse Events |
0; 0; 0 | — |
| SECONDARY Unanticipated Adverse Device Effects (UADE) |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Able to read, write, speak, and understand English
- Age: 29 days to 89 years
- Willing and able to provide informed consent and complete study procedures
- Willing to have Philips representatives present during study procedures.
Exclusion Criteria
- Known allergy to medical adhesives, silicone, or latex (per self-report)
- Any limitation or medical condition, including but not limited to physical or cognitive disability, that would affect the participant's ability to complete study activities (per investigator)
- At the time of enrollment, current enrollment in any other interventional research study
- An employee, or residing family member of an employee, of a company that designs, sells, or manufactures monitor/defibrillator technology or related products (including Philips)
Data sourced from ClinicalTrials.gov (NCT05636332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.