Pleural EffusionAINCT04891705
Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
An observational study of Pleural Effusion and Lung Consolidation, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pleural Effusion, Lung Consolidation
- What is being tested?
- Lung Ultrasound Scan
- Type of treatment
- Medical device
- How many people
- 554 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Sep 2021to 14 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Hospital
Aurora, Colorado, 80045
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Yale School of Medicine
New Haven, Connecticut, 06510
Arizona Emergency Medical Research Center
Tucson, Arizona, 85724
About this study
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.
Read the detailed description
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
- Pleural Effusion, Lung Consolidation
- Being tested
- Lung Ultrasound Scan
- Keywords
- Artificial Intelligence, Diagnostics
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Ultrasound ScanDevice
Ultrasound scan of subjects in up to 14 lung zones
| Study group | Role | What they receive |
|---|---|---|
| Pleural Effusion | Adult and pediatric subjects with suspicion of pleural effusion Receives: Device: Lung Ultrasound Scan | |
| Lung Consolidation | Adult and pediatric subjects with suspicion of lung consolidation Receives: Device: Lung Ultrasound Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Discharge up to 30 days (Single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start11 Sep 2021
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jochen Kruecker, Study director, Philips Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891705
- Sponsor's protocol ID
- US-Lung AI-11237
- Acronym
- AI
- Status last verified
- Nov 2023
- First submitted
- 13 May 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Ultrasound Lung Artificial Intelligence (AI) Validation Data Collection Study
- ClinicalTrials.gov ID
- NCT04891705
- Acronym / sponsor ID
- AI / US-Lung AI-11237
- Conditions
- Pleural Effusion, Lung Consolidation
- Keywords
- Artificial Intelligence, Diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 18 May 2021 (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.
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
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleural Effusion | – | Device: Lung Ultrasound ScanAdult and pediatric subjects with suspicion of pleural effusion |
| Lung Consolidation | – | Device: Lung Ultrasound ScanAdult and pediatric subjects with suspicion of lung consolidation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Lung Ultrasound ScanUltrasound scan of subjects in up to 14 lung zones | Device | Lung Consolidation, Pleural Effusion |
Primary outcome
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
Time frame: Discharge up to 30 days (Single visit)
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 15 Dec 2023.
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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.
Jochen Kruecker study director
Philips Healthcare
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion and Lung Consolidation, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
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 5 inclusion and 11 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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
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 (time frame: Discharge up to 30 days (Single visit)). 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 15 Dec 2023.