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

NCT05252130 | Completed FDA Device

• 1 other identifier: NoaScope-1 RMI
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope

Conditions

Chest Pathology

Outcome Measures

Primary Outcomes (2)

• Correctly identified abnormal heart and lung sounds by doctors using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III.

  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

• The measurement of sound quality in a clinical setting by means of an MOS scale on a questionnaire.

  The investigators will measure sound quality on a mean opinion score scale with values ranging form 1 (bad) to 5 (excellent).

  1 month

Secondary Outcomes (1)

• Difference in performance between subgroups of doctors based on clinical experience.

  1 month

Study Arms (1)

Auscultation with a newly developed electronic stethoscope: NoaScope

EXPERIMENTAL

Identification of abnormal heart and lung sounds in study participants

Device: NoaScope

Interventions

NoaScope DEVICE

Smart digital stethoscope

Auscultation with a newly developed electronic stethoscope: NoaScope

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Innova Smart Technologies (Pvt.) Ltd: lead
• Rehman Medical Institute - RMI: collaborator
• NOABIO LLC: collaborator

Study Sites (1)

Rehman Medical Institute - RMI

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: February 23, 2022
• Study Start: December 22, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 10, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)