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AI-Powered stethoscope aims to spot hidden Heart-Lung disease

NCT ID NCT05873387

Diagnosis Sponsor: Eko Devices, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This study is testing whether a special digital stethoscope, combined with artificial intelligence, can detect pulmonary hypertension (high blood pressure in the lungs) by listening to heart sounds and recording a single-lead ECG. Researchers will enroll over 2,400 adults who are already scheduled for heart ultrasound or right heart catheterization. The goal is to build a database and train an algorithm to identify the condition, potentially making diagnosis faster and less invasive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Eko DUO digital stethoscope (device)
What this could lead to
If successful, this could provide a quick, non-invasive way to screen for pulmonary hypertension using just a stethoscope, potentially catching the disease earlier.
What could go wrong
This is an early-stage data collection and algorithm development study. The AI may not reach the desired accuracy, and results from this large but single-device study may not generalize to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients will be enrolled from Miriam and Rhode Island Hospital and Cardiovascular Institute outpatient locations where echocardiography or right heart catheterizations are performed. Approximately 40% of the patients enrolled will have a confirmed diagnosis of pulmonary hypertension.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients, ages \>18 years, referred for complete 2-dimensional echocardiography or right heart catheterization will be screened for inclusion. Exclusion Criteria: * Patients undergoing limited echocardiography * Intubated patients

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Conditions

The condition(s) this trial relates to.

pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Providence VA Medical Center

    RECRUITING

    Providence, Rhode Island, 02908, United States

  • Rhode Island Hospital

    SUSPENDED

    Providence, Rhode Island, 02903, United States

  • The Miriam Hospital

    SUSPENDED

    Providence, Rhode Island, 02906, United States

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