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Completed

NCT Number: NCT04224753

INVSENSOR00027 Fall Detection Clinical Performance Study

This study assesses INVSENSOR00027's clinical performance for fall detection.

Completed

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Clinical Lab

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

INVSENSOR00027

Device

Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.

Primary outcomes

  1. Sensitivity of INVSENSOR00027's Fall Detection.

    Time frame: 1-5 hours

    For each subject's fall simulation, INVSENSOR00027 output will be computed. In order to calculate sensitivity of the device, true positives and false negatives need to be accounted for. For each event of fall, the sensor's output is observed. Fall that is correctly identified is marked as true positive (TP), whereas a missed detection is marked as false negative (FN). Combining the two, test sensitivity is computed by multiplying TP by 100 and dividing that over the sum of TP and FN.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2020
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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