Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds

April 4, 2023 updated by: Innova Smart Technologies (Pvt.) Ltd
Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The enrolled population will include adults with a history of heart and lung complications. The enhanced sound quality of the electronic stethoscope and its non-inferiority to the traditional/conventional 3M Littmann stethoscope will be assessed through auscultation examination of every patient by a health professional (consultant, medical resident, and house officer) with both the electronic stethoscope and 3M Littmann/traditional/conventional stethoscope

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KP
      • Peshawar, KP, Pakistan, 25000
        • Rehman Medical Institute - RMI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages: 18 years or older (male and female)
  • Hospital admitted or Out Patient Department
  • Written consent provided

Exclusion Criteria:

  • Age <18
  • ICU admitted
  • Written consent not provided

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auscultation with a newly developed electronic stethoscope: NoaScope
Identification of abnormal heart and lung sounds in study participants
Device: NoaScope
Smart digital stethoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The measurement of sound quality in a clinical setting by means of an MOS scale on a questionnaire.
Time Frame: 1 month
The investigators will measure sound quality on a mean opinion score scale with values ranging form 1 (bad) to 5 (excellent).
1 month
Correctly identified abnormal heart and lung sounds by doctors using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III.
Time Frame: 1 month

Each patient will receive two auscultation examinations: one with NoaScope and another with 3M™️ Littmann®️ Classic III.

The investigators will determine the clinical feasibility and non-inferiority of NoaScope to the FDA-approved 3M™️ Littmann®️ Classic III from auscultation findings (heart and lungs) by doctors (holding varied levels of clinical expertise). Doctors will examine each patient using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III. The investigators will also measure inter and intra observer agreement by the Kappa index with the help of a questionnaire. Kappa values < 0.8 means weak to moderate level of agreement and Kappa values between 0.8 - 1.0 would mean strong level of agreement.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in performance between subgroups of doctors based on clinical experience.
Time Frame: 1 month
This will be estimated as a proportion difference of correctly identified heart and lung sounds for each doctor subgroup.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innova Smart Technologies (Pvt.) Ltd

Collaborators

Rehman Medical Institute - RMI
NOABIO LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

February 10, 2022

Study Registration Dates

First Submitted

December 24, 2021

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NoaScope-1 RMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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