EmphysemaNCT07403617
Ventilation-Perfusion Discrepancy Index Versus Conventional Anatomic-Physiologic Assessment for Target Lung Lobe Selection in Endobronchial Valve Placement: A Multicenter, Randomised Controlled Trial
A study testing VQDI-assisted target lung lobe selection strategy and Conventional target lung lobe selection strategy in people with Emphysema, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if a Ventilation-Perfusion Discrepancy Index (VQDI)-guided strategy for selecting the target lung lobe can improve outcomes compared to the standard strategy in patients with severe emphysema undergoing bronchoscopic lung volume reduction with endobronchial valves (EBVs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- VQDI-assisted target lung lobe selection strategy and Conventional target lung lobe selection strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 285 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological evidence of emphysema
- Nonsmoking for 4 months prior to screening interview
- BMI less than 35 kg/m2
- Stable on current medication regimen
- Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
- Residual Volume less than 175% predicted (determined by body plethysmography)
- Little or no collateral ventilation (CV-) as determined using the Chartis System
Who cannot join
- Had two or more hospitalizations over the last year for a COPD exacerbation
- Had two or more hospitalizations over the last year for pneumonia
- Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
- Had a heart attack or congestive heart failure within the last 6 months
- Have heart arrhythmia
- Is alpha-1 antitrypsin deficient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Mingming Deng, +86 188-0133-6854, isdeng1017@163.com
About this study
The goal of this clinical trial is to learn if a Ventilation-Perfusion Discrepancy Index (VQDI)-guided strategy for selecting the target lung lobe can improve outcomes compared to the standard strategy in patients with severe emphysema undergoing bronchoscopic lung volume reduction with endobronchial valves (EBVs).
The main question it aims to answer is:
Read more
- Does selecting the target lobe based on the lowest VQDI (indicating the worst functional mismatch) lead to a higher rate of successful treatment response at 6 months compared to selecting the lobe based on the worst destruction on CT scan?
If there is a comparison group: Researchers will compare the VQDI-guided selection group to the conventional CT/Chartis-guided selection group to see which strategy results in more patients achieving significant improvement in both lung function and reduction in the size of the treated lobe.
Participants will:
- Undergo standard clinical assessments (lung function tests, CT scan, exercise test) and an additional V/Q SPECT/CT scan to calculate the VQDI.
- Have their collateral ventilation status checked using the Chartis system during bronchoscopy.
- Be randomly assigned to one of the two target lobe selection strategies.
- Receive EBV placement in the selected lobe.
- Attend follow-up visits at 1, 3, 6, and 12 months after the procedure for check-ups, repeated lung function tests, questionnaires, and CT scans to assess their response to treatment.
- Conditions
- Emphysema
- Being tested
- VQDI-assisted target lung lobe selection strategy, Conventional target lung lobe selection strategy
- Keywords
- Endobronchial Lung Volume Reduction, Ventilation-Perfusion Discrepancy Index, Emphysema, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VQDI-assisted target lung lobe selection strategyProcedure or surgery
Participants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected specifically based on functional imaging. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the lowest Ventilation-Perfusion Discrepancy Index (VQDI) - indicating the most severe mismatch between air flow and blood flow - is chosen for treatment. All other procedural aspects, screening assessments, and follow-up are identical to the comparator arm.
Conventional target lung lobe selection strategyProcedure or surgery
Participants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected based on standard anatomical criteria. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the highest CT destruction score - indicating the most severe anatomical emphysema - is chosen for treatment. This reflects current standard-of-care practice. All other procedural aspects, screening assessments, and follow-up are identical to the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| VQDI-assisted target lung lobe selection strategy | Experimental | Target lobe selection is based on the lobe with the lowest VQDI among all lobes with an absence of collateral ventilation (Chartis-negative), indicating the most severe ventilation-perfusion mismatch. Receives: Procedure: VQDI-assisted target lung lobe selection strategy |
| Conventional target lung lobe selection strategy | Placebo comparator | Target lobe selection is based on the lobe with the highest CT destruction score among all lobes with an absence of collateral ventilation (Chartis-negative), indicating the most severe anatomical destruction. Receives: Procedure: Conventional target lung lobe selection strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation-Perfusion Discrepancy Index (VQDI)
The absolute change in the target lobe's VQDI from baseline to 6 months post-procedure.
Measured: 6 month
Secondary outcomes (3)
St. George's Respiratory Questionnaire (SGRQ)
Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline). The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 1 year
FEV1 Post-bronchodilator Absolute Change
Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).
Measured: 1 year
6-minute Walk Distance
Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 285 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
- NCT07403617
- Sponsor's protocol ID
- SELECTION-I
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation-Perfusion Discrepancy Index Versus Conventional Anatomic-Physiologic Assessment for Target Lung Lobe Selection in Endobronchial Valve Placement: A Multicenter, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07403617
- Acronym / sponsor ID
- SELECTION-I
- Conditions
- Emphysema
- Keywords
- Endobronchial Lung Volume Reduction, Ventilation-Perfusion Discrepancy Index, Emphysema, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 11 Feb 2026 (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 this clinical trial is to learn if a Ventilation-Perfusion Discrepancy Index (VQDI)-guided strategy for selecting the target lung lobe can improve outcomes compared to the standard strategy in patients with severe emphysema undergoing bronchoscopic lung volume reduction with endobronchial valves (EBVs).
The main question it aims to answer is:
- Does selecting the target lobe based on the lowest VQDI (indicating the worst functional mismatch) lead to a higher rate of successful treatment response at 6 months compared to selecting the lobe based on the worst destruction on CT scan?
If there is a comparison group: Researchers will compare the VQDI-guided selection group to the conventional CT/Chartis-guided selection group to see which strategy results in more patients achieving significant improvement in both lung function and reduction in the size of the treated lobe.
Participants will:
- Undergo standard clinical assessments (lung function tests, CT scan, exercise test) and an additional V/Q SPECT/CT scan to calculate the VQDI.
- Have their collateral ventilation status checked using the Chartis system during bronchoscopy.
- Be randomly assigned to one of the two target lobe selection strategies.
- Receive EBV placement in the selected lobe.
- Attend follow-up visits at 1, 3, 6, and 12 months after the procedure for check-ups, repeated lung function tests, questionnaires, and CT scans to assess their response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VQDI-assisted target lung lobe selection strategy | Experimental | Procedure: VQDI-assisted target lung lobe selection strategyTarget lobe selection is based on the lobe with the lowest VQDI among all lobes with an absence of collateral ventilation (Chartis-negative), indicating the most severe ventilation-perfusion mismatch. |
| Conventional target lung lobe selection strategy | Placebo comparator | Procedure: Conventional target lung lobe selection strategyTarget lobe selection is based on the lobe with the highest CT destruction score among all lobes with an absence of collateral ventilation (Chartis-negative), indicating the most severe anatomical destruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical and radiological evidence of emphysema
- Nonsmoking for 4 months prior to screening interview
- BMI less than 35 kg/m2
- Stable on current medication regimen
- Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
Key exclusion criteria (6 listed)
- Had two or more hospitalizations over the last year for a COPD exacerbation
- Had two or more hospitalizations over the last year for pneumonia
- Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
- Had a heart attack or congestive heart failure within the last 6 months
- Have heart arrhythmia
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 |
|---|---|---|
| VQDI-assisted target lung lobe selection strategyParticipants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected specifically based on functional imaging. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the lowest Ventilation-Perfusion Discrepancy Index (VQDI) - indicating the most severe mismatch between air flow and blood flow - is chosen for treatment. All other procedural aspects, screening assessments, and follow-up are identical to the comparator arm. | Procedure or surgery | VQDI-assisted target lung lobe selection strategy |
| Conventional target lung lobe selection strategyParticipants in this arm undergo endobronchial valve (EBV) placement in a target lobe selected based on standard anatomical criteria. Among all lobes confirmed to have no collateral ventilation (assessed by the Chartis system), the lobe with the highest CT destruction score - indicating the most severe anatomical emphysema - is chosen for treatment. This reflects current standard-of-care practice. All other procedural aspects, screening assessments, and follow-up are identical to the experimental arm. | Procedure or surgery | Conventional target lung lobe selection strategy |
Primary outcome
Ventilation-Perfusion Discrepancy Index (VQDI)
Time frame: 6 month
The absolute change in the target lobe's VQDI from baseline to 6 months post-procedure.
3 secondary outcomes
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 1 year
FEV1 Post-bronchodilator Absolute Change
Time frame: 1 year
6-minute Walk Distance
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VQDI-assisted target lung lobe selection strategy and Conventional target lung lobe selection strategy in people with Emphysema, 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 6 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: opening soon, as of the sponsor's last update on 11 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingming Deng, Ph.D., M.D. (+86 188-0133-6854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation-Perfusion Discrepancy Index (VQDI) (time frame: 6 month). 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 11 Feb 2026.