Chest PathologyNCT05252130
Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
A study testing NoaScope in people with Chest Pathology, run by Innova Smart Technologies (Pvt.) Ltd at 1 site in Pakistan.
Trial summary
Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chest Pathology
- What is being tested?
- NoaScope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Dec 2021to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages: 18 years or older (male and female)
- Hospital admitted or Out Patient Department
- Written consent provided
Who cannot join
- Age <18
- ICU admitted
- Written consent not provided
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rehman Medical Institute - RMI
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope
Read the 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
- Conditions
- Chest Pathology
- Being tested
- NoaScope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoaScopeDevice
Smart digital stethoscope
| Study group | Role | What they receive |
|---|---|---|
| Auscultation with a newly developed electronic stethoscope: NoaScope | Experimental | Identification of abnormal heart and lung sounds in study participants Receives: Device: NoaScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start22 Dec 2021
- Primary completion31 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innova Smart Technologies (Pvt.) Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Rehman Medical Institute - RMI, NOABIO LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252130
- Sponsor's protocol ID
- NoaScope-1 RMI
- Status last verified
- Apr 2023
- First submitted
- 24 Dec 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
- ClinicalTrials.gov ID
- NCT05252130
- Acronym / sponsor ID
- NoaScope-1 RMI
- Conditions
- Chest Pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Innova Smart Technologies (Pvt.) LtdUniversity, hospital or other
- Collaborators
- Rehman Medical Institute - RMI, NOABIO LLC
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auscultation with a newly developed electronic stethoscope: NoaScope | Experimental | Device: NoaScopeIdentification of abnormal heart and lung sounds in study participants |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages: 18 years or older (male and female)
- Hospital admitted or Out Patient Department
- Written consent provided
Key exclusion criteria (3 listed)
- Age <18
- ICU admitted
- Written consent not provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NoaScopeSmart digital stethoscope | Device | Auscultation with a newly developed electronic stethoscope: NoaScope |
Primary outcome
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.
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 secondary outcome
Difference in performance between subgroups of doctors based on clinical experience.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NoaScope in people with Chest Pathology, run by Innova Smart Technologies (Pvt.) Ltd at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correctly identified abnormal heart and lung sounds by doctors using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.