PneumothoraxNCT05903209
A Study to Evaluate Chang Gung Pneumothorax Detection Software
An observational study of Pneumothorax, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The Chang Gung Pneumothorax Detection Software is a medical software that can automatically detect whether there is a pneumothorax in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pneumothorax Detection Software can correctly identify patients with pneumothorax in Chest X-Ray. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Chang Gung Pneumothorax Detection Software
- Type of treatment
- Medical device
- How many people
- 344 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jun 2022to 12 Jan 2024
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective study, and the data comes from the Chang Gung Medical Research Database(CGRD) which was an database form 6 hospitals of Chang Gung Memorial hospital. According to inclusion and exclusion criteria, Chest X-ray data from the database during 2006.01.01~2020.12.31 was collected.
Who may be able to join
- The case were over 20 years old and under 100 years old.
- DICOM format.
- Brand model of Canon.
- DICOM resolution length range (700-3400 pixels), width range (490-3600 pixels).
- poster-anterior view(PA-view) of chest X-ray
Who cannot join
- The chest X-ray contains items that affect interpretation, such as chest tubes, endotracheal tubes, and heart rhythm regulators, but does not include patches and circuits used in electrocardiograms.
- The chest X-ray that are difficult to interpret due to poor image quality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Accuracy and Validity of Chang Gung Pneumothorax Detection Software Compared With Reference by Qualified Physicians
The Chang Gung Pneumothorax Detection Software is a medical software that can automatically detect whether there is a pneumothorax in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pneumothorax Detection Software can correctly identify patients with pneumothorax in Chest X-Ray. The results of the software analysis will be used for the performance of the software on the primary and secondary outcomes.
Read the detailed description
This clinical trial is a retrospective study. DICOM images of de-identified Chest X-Ray were collected from 6 hospitals of Chang Gung Memorial Hospital from January 1, 2006 to December 31, 2020. The test set of 5,347 items was established, and total of 344 cases will be sampled by simple random stratification, including 172 cases with pneumothorax and 172 cases without pneumothorax. The image must be in DICOM format.
Follow-up by three specialist physicians to interpret the presence or absence of pneumothorax, the result will be the standard of this test (Reference). After confirming the correct standard of each Chest X-Ray, the Chest X-Ray will be put into Chang Gung Pneumothorax Detection Software, and analyzed by the primary and secondary outcomes.
- Conditions
- Pneumothorax
- Being tested
- Chang Gung Pneumothorax Detection Software
- Keywords
- artificial intelligence
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chang Gung Pneumothorax Detection SoftwareDevice
The Chang Gung Pneumothorax Detection Software is an independent software as a medical device, which inputs digital Chest X-Ray to automatically detect whether there is a pneumothorax. The inferred results output by this software can assist clinicians or professional medical personnel to identify whether a patient has pneumothorax.
This product is only used to analyze the digitized Chest X-Ray DICOM of patients over 20 years old and under 100 years old.
| Study group | Role | What they receive |
|---|---|---|
| Software diagnosis | Software diagnosis with gold standard of 3 doctors' interpretation. Receives: Device: Chang Gung Pneumothorax Detection Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The rate of test results that correctly indicate the presence.
Measured: baseline
Secondary outcomes (2)
Specificity
The rate of test results that correctly indicate the absence.
Measured: baseline
Area Under the receiver operating characteristic Curve
A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start13 Jun 2022
- Primary completion15 Dec 2023
- Study completion12 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang-Fu Kuo, Study chair, Associate Professor and Director Division of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903209
- Sponsor's protocol ID
- 202200871B0
- Status last verified
- May 2023
- First submitted
- 6 Jun 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ebrahimi A, Yousefifard M, Mohammad Kazemi H, Rasouli HR, Asady H, Moghadas Jafari A, Hosseini M. Diagnostic Accuracy of Chest Ultrasonography versus Chest Radiography for Identification of Pneumothorax: A Systematic Review and Meta-Analysis. Tanaffos. 2014;13(4):29-40.
PubMed 25852759Nagarsheth K, Kurek S. Ultrasound detection of pneumothorax compared with chest X-ray and computed tomography scan. Am Surg. 2011 Apr;77(4):480-4.
PubMed 21679560Nandipati KC, Allamaneni S, Kakarla R, Wong A, Richards N, Satterfield J, Turner JW, Sung KJ. Extended focused assessment with sonography for trauma (EFAST) in the diagnosis of pneumothorax: experience at a community based level I trauma center. Injury. 2011 May;42(5):511-4. doi: 10.1016/j.injury.2010.01.105. Epub 2010 Feb 10.
PubMed 20149371Lachin JM. Properties of simple randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):312-26. doi: 10.1016/0197-2456(88)90046-3.
PubMed 3203523Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
PubMed 21772732Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019 Jun;72(3):221-232. doi: 10.4097/kja.19049. Epub 2019 Apr 1.
PubMed 30929415
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Accuracy and Validity of Chang Gung Pneumothorax Detection Software Compared With Reference by Qualified Physicians
- ClinicalTrials.gov ID
- NCT05903209
- Acronym / sponsor ID
- 202200871B0
- Conditions
- Pneumothorax
- Keywords
- artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 12 Jan 2024 (estimated)
- First posted
- 15 Jun 2023 (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.
The Chang Gung Pneumothorax Detection Software is a medical software that can automatically detect whether there is a pneumothorax in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pneumothorax Detection Software can correctly identify patients with pneumothorax in Chest X-Ray. The results of the software analysis will be used for the performance of the software on the primary and secondary outcomes.
Detailed description
This clinical trial is a retrospective study. DICOM images of de-identified Chest X-Ray were collected from 6 hospitals of Chang Gung Memorial Hospital from January 1, 2006 to December 31, 2020. The test set of 5,347 items was established, and total of 344 cases will be sampled by simple random stratification, including 172 cases with pneumothorax and 172 cases without pneumothorax. The image must be in DICOM format.
Follow-up by three specialist physicians to interpret the presence or absence of pneumothorax, the result will be the standard of this test (Reference). After confirming the correct standard of each Chest X-Ray, the Chest X-Ray will be put into Chang Gung Pneumothorax Detection Software, and analyzed by the primary and secondary outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Software diagnosis | – | Device: Chang Gung Pneumothorax Detection SoftwareSoftware diagnosis with gold standard of 3 doctors' interpretation. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective study, and the data comes from the Chang Gung Medical Research Database(CGRD) which was an database form 6 hospitals of Chang Gung Memorial hospital. According to inclusion and exclusion criteria, Chest X-ray data from the database during 2006.01.01~2020.12.31 was collected.
Key inclusion criteria (5 listed)
- The case were over 20 years old and under 100 years old.
- DICOM format.
- Brand model of Canon.
- DICOM resolution length range (700-3400 pixels), width range (490-3600 pixels).
- poster-anterior view(PA-view) of chest X-ray
Key exclusion criteria (2 listed)
- The chest X-ray contains items that affect interpretation, such as chest tubes, endotracheal tubes, and heart rhythm regulators, but does not include patches and circuits used in electrocardiograms.
- The chest X-ray that are difficult to interpret due to poor image quality.
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 |
|---|---|---|
| Chang Gung Pneumothorax Detection SoftwareThe Chang Gung Pneumothorax Detection Software is an independent software as a medical device, which inputs digital Chest X-Ray to automatically detect whether there is a pneumothorax. The inferred results output by this software can assist clinicians or professional medical personnel to identify whether a patient has pneumothorax. This product is only used to analyze the digitized Chest X-Ray DICOM of patients over 20 years old and under 100 years old. | Device | Software diagnosis |
Primary outcome
Sensitivity
Time frame: baseline
The rate of test results that correctly indicate the presence.
2 secondary outcomes
Specificity
Time frame: baseline
Area Under the receiver operating characteristic Curve
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 25852759Ebrahimi A, Yousefifard M, Mohammad Kazemi H, Rasouli HR, Asady H, Moghadas Jafari A, Hosseini M. Diagnostic Accuracy of Chest Ultrasonography versus Chest Radiography for Identification of Pneumothorax: A Systematic Review and Meta-Analysis. Tanaffos. 2014;13(4):29-40.
- Background: PubMed 21679560Nagarsheth K, Kurek S. Ultrasound detection of pneumothorax compared with chest X-ray and computed tomography scan. Am Surg. 2011 Apr;77(4):480-4.
- Background: PubMed 20149371Nandipati KC, Allamaneni S, Kakarla R, Wong A, Richards N, Satterfield J, Turner JW, Sung KJ. Extended focused assessment with sonography for trauma (EFAST) in the diagnosis of pneumothorax: experience at a community based level I trauma center. Injury. 2011 May;42(5):511-4. doi: 10.1016/j.injury.2010.01.105. Epub 2010 Feb 10.
- Background: PubMed 3203523Lachin JM. Properties of simple randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):312-26. doi: 10.1016/0197-2456(88)90046-3.
- Background: PubMed 21772732Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
- Background: PubMed 30929415Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019 Jun;72(3):221-232. doi: 10.4097/kja.19049. Epub 2019 Apr 1.
- 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.
Chang-Fu Kuo study chair
Associate Professor and Director Division of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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 Taiwan. 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?
Results are not available in the source record.
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?
Sensitivity (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05903209, which also lists 6 linked publications.
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 11 Jan 2024.