N/A
N=51
INVSENSOR00027 Fall Detection Clinical Performance Study
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04224753 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Sensitivity of INVSENSOR00027's Fall Detection. — 93.9 percentage of falls detected
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- INVSENSOR00027 (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of INVSENSOR00027's Fall Detection. |
93.9 | — |
Summary
This study assesses INVSENSOR00027's clinical performance for fall detection.
Eligibility Criteria
Inclusion Criteria
- 18 to 45 years old
- Physical status of ASA I or II
- Subjects must be able to read and communicate in English
- Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
- Has completed Health Assessment Questionnaire and passed health assessment screening
Exclusion Criteria
- Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
- Inability to tolerate physical activities including jumping and fall simulation
- Nursing female volunteers
- Excluded at the Principal Investigator's discretion
- Refusal to take the pregnancy test (for female subjects)
- Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
- Refusal to shave hair (chest) off areas where sensors will be applied (male subjects)
Data sourced from ClinicalTrials.gov (NCT04224753). 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.