Chronic Obstructive Pulmonary DiseaseNCT05799040
Evaluation of the Effectiveness of the Self-developed Pulmonary Lobar Ventilation Detector
An observational study of Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The goal of observational study is to Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector. 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?
- Self-developed pulmonary lobar ventilation detector and Chartis detection system
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 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 disease
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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Gang Hou, Professor, 13840065481, hougangcmu@163.com
Mingming Deng, Doctor, 18801336854, isdeng1017@163.com
About this study
The goal of observational study is to Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector.
Participants will use the self-developed pulmonary lobar ventilation detector and the imported Chartis detection system to evaluate the target pulmonary lobar collateral ventilation.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Self-developed pulmonary lobar ventilation detector, 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.
Self-developed pulmonary lobar ventilation detectorDevice
The participants would evaluated by the self-developed pulmonary lobar ventilation detector.
Chartis detection systemDevice
The participants would evaluated by the Chartis detection system.
| Study group | Role | What they receive |
|---|---|---|
| Self-developed pulmonary lobar ventilation detector | Not described Receives: Device: Self-developed pulmonary lobar ventilation detector | |
| imported Chartis detection system | Not described Receives: Device: 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
Use the self-developed pulmonary lobar ventilation detector and the imported Chartis detection system to evaluate the target pulmonary lobar collateral ventilation
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 posted5 Apr 2023
- Study start26 Oct 2023
- 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
- NCT05799040
- Sponsor's protocol ID
- 2022-NHLHCRF-LX-01-0202-3
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2023
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Self-developed Pulmonary Lobar Ventilation Detector
- ClinicalTrials.gov ID
- NCT05799040
- Acronym / sponsor ID
- 2022-NHLHCRF-LX-01-0202-3
- 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 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 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 Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector in Chronic Obstructive Pulmonary Disease. The main question it aims to answer are:Evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector.
Participants will use the self-developed pulmonary lobar ventilation detector and the imported Chartis detection system to evaluate the target pulmonary lobar collateral ventilation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-developed pulmonary lobar ventilation detector | – | Device: Self-developed pulmonary lobar ventilation detector |
| imported Chartis detection system | – | Device: 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 disease
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 |
|---|---|---|
| Self-developed pulmonary lobar ventilation detectorThe participants would evaluated by the self-developed pulmonary lobar ventilation detector. | Device | Self-developed pulmonary lobar ventilation detector |
| Chartis detection systemThe participants would evaluated by the Chartis detection system. | Device | 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
Use the self-developed pulmonary lobar ventilation detector and the imported Chartis detection system to evaluate the target pulmonary lobar collateral ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
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 Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
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 12 Mar 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 China. 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?
Contact Mingming Deng, MD (86 18801336854, isdeng1017@163.com), or a site near the patient. 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 12 Mar 2024.