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

NCT04891705 | Completed FDA Device

• 1 other identifier: US-Lung AI-11237
• Study Type: observational
• Target: 554
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Pleural Effusion; Lung Consolidation

Keywords

Artificial Intelligence; Diagnostics

Outcome Measures

Primary Outcomes (1)

• The study data will be used to support future performance assessments for Artificial Intelligence based algorithms as described by FDA guidance for Computer Assisted Detection and Diagnostic Devices

  Discharge up to 30 days (Single visit)

Study Arms (2)

Pleural Effusion

Adult and pediatric subjects with suspicion of pleural effusion

Device: Lung Ultrasound Scan

Lung Consolidation

Adult and pediatric subjects with suspicion of lung consolidation

Device: Lung Ultrasound Scan

Interventions

Lung Ultrasound Scan DEVICE

Ultrasound scan of subjects in up to 14 lung zones

Lung Consolidation; Pleural Effusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with suspicion of pleural effusion or lung consolidation will be enrolled in the study. In addition, pediatric subjects with suspicion of lung consolidation (with weight of at least 10 kg) will be enrolled.

You may qualify if:

• 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.
• 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.
• 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.
• Weight of subject is greater than or equal to 10 kg.

You may not qualify if:

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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (5)

Arizona Emergency Medical Research Center

Tucson, Arizona, 85724, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Jochen Kruecker

  Philips Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 18, 2021
• Study Start: September 11, 2021
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-11

Locations

US (5)