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Wearable Auscultation Device Validation in Children

NCT06112080 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2024-07-05

No results posted yet for this study

Summary

This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.

Conditions

  • Asthma
  • Asthma in Children
  • Wheezing
  • Pediatric Asthma

Interventions

DEVICE

RESP™ Biosensor

The RESP™ Biosensor will be placed on all participants for immediate capture and comparison of lung sounds.

Sponsors & Collaborators

  • Strados Labs, Inc.

    lead INDUSTRY

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2024-06-24
Completion
2024-06-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06112080 on ClinicalTrials.gov