MedDataX Logo

Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study

NCT ID: NCT04891705

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

554 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-11

Study Completion Date

2023-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is being conducted to collect image data and relevant clinical data from medical records of patients with suspicion of lung consolidation or pleural effusion. The information will be used to test the performance of Artificial Intelligence (AI) in identification of features associated with the above lung conditions.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, observational, multi-center, post-market clinical study. Enrollment will continue (up to a maximum of 500 adult subjects and up to 300 pediatric subjects) until diagnostic LUS exams are acquired for each of the following groups:

Approximately 500 Adult subjects targeting:

* Approximately 175 exams from patients positive for lung consolidation
* Approximately 175 exams from patients positive for pleural effusion
* Approximately 150 exams from patients negative for both conditions

Approximately 300 pediatric subjects targeting:

* Approximately 150 exams from patients positive for lung consolidation
* Approximately 150 exams from patients negative for lung consolidation

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pleural Effusion Lung Consolidation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Artificial Intelligence Diagnostics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pleural Effusion

Adult and pediatric subjects with suspicion of pleural effusion

Lung Ultrasound Scan

Intervention Type DEVICE

Ultrasound scan of subjects in up to 14 lung zones

Lung Consolidation

Adult and pediatric subjects with suspicion of lung consolidation

Lung Ultrasound Scan

Intervention Type DEVICE

Ultrasound scan of subjects in up to 14 lung zones

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lung Ultrasound Scan

Ultrasound scan of subjects in up to 14 lung zones

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subjects presenting to the Emergency Department, admitted to the hospital, or seen in the outpatient setting with suspicion of pleural effusion or lung consolidation who received chest imaging to include chest X-ray or CT, or for whom chest X-ray or CT are planned.

Suspicion of pleural effusion or lung consolidation may be based upon imaging findings or presentation of symptoms including (but not limited to) dyspnea, hypoxia, tachypnea, rales, or dullness.
2. All attempts should be made for subjects to undergo scanning of 14 lung zones (adults) and 12 lung zones (pediatrics). Attempts should also be made to capture all required lung zones in adults and pediatrics. Instances where all zones cannot be captured need to be documented and reason for inability to scan them provided in EDC. See Section 8.1.3 Lung Ultrasound Exams.
3. Subject is willing to provide informed consent (or assent where age appropriate) to participate in the study. Subjects under 18 years of age require informed consent of a parent or guardian and assent as required by institutional IRB.
4. Weight of subject is greater than or equal to 10 kg.

Exclusion Criteria

1. Subject has pathology precluding safe and pain-free ultrasound probe placement such as burn, significant soft tissue injury or surgical incisions.
2. Current imprisonment.
3. Pregnancy (self-reported)
4. Subjects with breast implants
5. Prior pleurodesis procedure.
6. History of severe lung disease and home oxygen use
7. Presence of subcutaneous air that precludes imaging
8. Body Mass Index (BMI) \> 40
9. Significant scoliosis (Cobb angle ≥ 20 degrees).
10. Pediatric subjects with chronic lung diseases other than asthma.
11. Pediatric subjects on chronic respiratory support (i.e., nasal canula, CPAP, BiPAP, or tracheostomy).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jochen Kruecker

Role: STUDY_DIRECTOR

Philips Healthcare

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona Emergency Medical Research Center

Tucson, Arizona, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

US-Lung AI-11237

Identifier Type: -

Identifier Source: org_study_id