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The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

NCT05629533 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2026-04-09

No results posted yet for this study

Summary

The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases. Phase 1 will use SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.' Phase 2 will evaluate the algorithms developed to estimate cardiac output from SimpleSense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.

Conditions

  • Right Heart Catheterization

Interventions

DEVICE

SimpleSense

The study is observational only. No interventions will be triggered by the SimpleSense device

Sponsors & Collaborators

  • Westchester Medical Center

    collaborator OTHER

  • Nanowear Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-08
Primary Completion
2025-03-05
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629533 on ClinicalTrials.gov