An interventional study of NoaScope in Chest Pathology, sponsored by Innova Smart Technologies (Pvt.) Ltd. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Innova Smart Technologies (Pvt.) Ltd · Not applicable, Interventional, and Diagnostic
Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope
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
143 studies on the registry are indexed under Respiratory Sounds; 32 are open to participants now.
This study's enrollment of 47 is below the median of 100 across 75 interventional studies indexed under Respiratory Sounds.
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Exclusion Criteria:
Identification of abnormal heart and lung sounds in study participants
Device: NoaScope
Smart digital stethoscope
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.
Time frame: 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).
Time frame: 1 month
Difference in performance between subgroups of doctors based on clinical experience.
This will be estimated as a proportion difference of correctly identified heart and lung sounds for each doctor subgroup.
Time frame: 1 month
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Innova Smart Technologies (Pvt.) Ltd