Chronic Obstructive Pulmonary DiseaseNCT05774730
Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI Technology
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
Trial summary
The goal of observational study is to evaluate effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology in patients with Chronic Obstructive Pulmonary Disease who will undergo lung volume reduction surgery with endobronchial valve implantation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Emphysema quantitative analysis software based on chest image AI technology, artificial analysis of chest image and imported Chartis detection system
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2023to 31 Dec 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic obstructive pulmonary diseases
Who may be able to join
- Patients with chronic obstructive pulmonary disease who meet the GOLD diagnostic criteria
- FEV1 ≤ 45% pred and FEV1/FVC<70%
- TLC>100% pred and RV>175% pred
- CAT≥18
- >50% of emphysema destruction
- Smoking prohibition>6 months
- Sign the informed consent form
Who cannot join
- PaCO2>8.0 kPa, or PaO2<6.0 kPa
- 6-minute walking test<160m
- Obvious chronic bronchitis, bronchiectasis or other infectious lung diseases
- Three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment
- Previous lobectomy, LVRS or lung transplantation
- LVEF<45% and or RVSP>50mmHg
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- Anticoagulant therapy that cannot be stopped before surgery
- The patient has obvious immune deficiency
- Participated in other lung drug studies within 30 days before this study
- Pulmonary nodules requiring intervention
- Any disease or condition that interferes with the completion of the initial or subsequent assessment
About this study
The goal of observational study is to evaluate effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology in patients with Chronic Obstructive Pulmonary Disease who will undergo lung volume reduction surgery with endobronchial valve implantation. The main question it aims to answer is: evaluation of the effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology.
Participants will be evaluated by lung CT (quantitative analysis based on chest image AI technology and artificial analysis) and imported Chartis detection system.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Emphysema quantitative analysis software based on chest image AI technology, artificial analysis of chest image, imported Chartis detection system
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emphysema quantitative analysis software based on chest image AI technologyOther
The participants would undergo lung CT, and the integrity of interlobar fissure will be quantitatively analyses by software based on chest image AI technology.
artificial analysis of chest imageOther
The participants would undergo lung CT, and the integrity of interlobar fissure will be artificially analyses.
imported Chartis detection systemProcedure or surgery
The participants would undergo imported Chartis detection system.
| Study group | Role | What they receive |
|---|---|---|
| Emphysema quantitative analysis softwarebased on chest image AI technology | Not described Receives: Other: Emphysema quantitative analysis software based on chest image AI technology | |
| artificial analysis | Not described Receives: Other: artificial analysis of chest image | |
| imported Chartis detection system | Not described Receives: Procedure: imported Chartis detection system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic effect of lung volume reduction surgery
Lung CT
Measured: 1 month after bronchoscopic valve lung volume reduction
Therapeutic effect of lung volume reduction surgery
Lung CT
Measured: 3 months after bronchoscopic valve lung volume reduction
Therapeutic effect of lung volume reduction surgery
Lung CT
Measured: 6 months after bronchoscopic valve lung volume reduction
the integrity of interlobar fissure
Emphysema quantitative analysis softwarebased on chest image AI technology, artificial analysis and imported Chartis detection system
Measured: Before bronchoscopic valve lung volume reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start26 Mar 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774730
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0202-2
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI Technology
- ClinicalTrials.gov ID
- NCT05774730
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0202-2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 26 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Mar 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 goal of observational study is to evaluate effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology in patients with Chronic Obstructive Pulmonary Disease who will undergo lung volume reduction surgery with endobronchial valve implantation. The main question it aims to answer is: evaluation of the effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology.
Participants will be evaluated by lung CT (quantitative analysis based on chest image AI technology and artificial analysis) and imported Chartis detection system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emphysema quantitative analysis softwarebased on chest image AI technology | – | Other: Emphysema quantitative analysis software based on chest image AI technology |
| artificial analysis | – | Other: artificial analysis of chest image |
| imported Chartis detection system | – | Procedure: imported Chartis detection system |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic obstructive pulmonary diseases
Key inclusion criteria (7 listed)
- Patients with chronic obstructive pulmonary disease who meet the GOLD diagnostic criteria
- FEV1 ≤ 45% pred and FEV1/FVC<70%
- TLC>100% pred and RV>175% pred
- CAT≥18
- >50% of emphysema destruction
Key exclusion criteria (11 listed)
- PaCO2>8.0 kPa, or PaO2<6.0 kPa
- 6-minute walking test<160m
- Obvious chronic bronchitis, bronchiectasis or other infectious lung diseases
- Three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment
- Previous lobectomy, LVRS or lung transplantation
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 |
|---|---|---|
| Emphysema quantitative analysis software based on chest image AI technologyThe participants would undergo lung CT, and the integrity of interlobar fissure will be quantitatively analyses by software based on chest image AI technology. | Other | Emphysema quantitative analysis softwarebased on chest image AI technology |
| artificial analysis of chest imageThe participants would undergo lung CT, and the integrity of interlobar fissure will be artificially analyses. | Other | artificial analysis |
| imported Chartis detection systemThe participants would undergo imported Chartis detection system. | Procedure or surgery | imported Chartis detection system |
Primary outcome
Therapeutic effect of lung volume reduction surgery
Time frame: 1 month after bronchoscopic valve lung volume reduction
Lung CT
Therapeutic effect of lung volume reduction surgery
Time frame: 3 months after bronchoscopic valve lung volume reduction
Lung CT
Therapeutic effect of lung volume reduction surgery
Time frame: 6 months after bronchoscopic valve lung volume reduction
Lung CT
the integrity of interlobar fissure
Time frame: Before bronchoscopic valve lung volume reduction
Emphysema quantitative analysis softwarebased on chest image AI technology, artificial analysis and imported Chartis detection system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital.
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 7 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: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Therapeutic effect of lung volume reduction surgery (time frame: 1 month after bronchoscopic valve lung volume reduction). The study lists 4 primary outcomes in all. 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 21 Mar 2023.