Status:

TERMINATED

Wearable Auscultation Device Validation in Children

Lead Sponsor:

Strados Labs, Inc.

Conditions:

Asthma

Asthma in Children

Eligibility:

All Genders

4-17 years

Brief 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, sur...

Eligibility Criteria

Inclusion

  • Any child aged 4-17 years of age
  • Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
  • Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)
  • Admitted for a non-respiratory complaint
  • Normal breath sounds on screening examination
  • Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)
  • Admitted for pathologic process that may lead to wheezing (e.g., asthma)
  • Presence of wheeze on screening examination

Exclusion

  • Children less than age 4, adults (age 18 and above)
  • Patients in the ambulatory setting
  • Unable to provide consent
  • Intubated patients
  • Unstable disease posing a threat to life
  • Adhesive allergy

Key Trial Info

Start Date :

August 7 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 24 2024

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT06112080

Start Date

August 7 2023

End Date

June 24 2024

Last Update

July 5 2024

Active Locations (1)

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1

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611