COPDREPEATNCT06181357
Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves
A study testing Endoscopic lung volume reduction in 2 stages and Endoscopic lung volume reduction in 1 stage in people with COPD, run by University Hospital, Limoges at 17 sites in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Endoscopic lung volume reduction in 2 stages and Endoscopic lung volume reduction in 1 stage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 17 sitesFrance
- Study dates
- 6 May 2024to 6 Jun 2029
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient able to give informed consent and participate in the study
- Age ≥ 35 years old and ≤ 80 years old at the time of signing the consent
- Emphysema (homogeneous or heterogeneous) on a recent CT scan (< 6 months). Heterogeneous emphysema defined by a difference of at least 15% destruction (threshold 910HU) between two adjacent lobes.
- Destruction ≥ 50% (threshold 910 HU) of the target lobe on the chest scanner
- Smoking quit for 3 months
- Dyspnea ≥ 2 according to the modified Medical Research Council (mMRC) questionnaire)
Show all 10Show fewer
- Post-bronchodilator FEV between 15 and 50% theoretical
- Post-bronchodilator total lung capacity ≥ 100% theoretical and post-bronchodilator residual volume ≥ 175% theoretical
- Distance traveled during the TM6M ≥ 100m
- Member of or beneficiary of a social security scheme
Who cannot join
- Asthma considered as main diagnosis
- Recurrent exacerbations: (>3 over the last year or 2 requiring hospitalization)
- Myocardial infarction or stroke in the 6 months prior to inclusion
- Symptoms of heart failure in the 6 months prior to inclusion
- Chest CT abnormalities: giant bulla (occupying more than a third of the pulmonary field), paraseptal emphysema, pulmonary nodule greater than 0.8cm (not applicable pulmonary nodules known for more than a year and stable), fibrosing interstitial pneumonitis, dilated bronchi
- Pulmonary tomoscintigraphy:
Show all 25Show fewer
- Patients for whom the least perfused lobe is not the one with the highest emphysema destruction score
- Patients with homogeneous emphysema for whom the perfusion delta (difference in perfusion between the ipsilateral lung and the treated lobe) is less than 10%
- Arterial blood gas analysis in ambient air: Hypoxemia in ambient air (PaO2 < 45 mmHg). Hypercapnia (PaCO2 > 55 mmHg)
- Echocardiography:
- Left Ventricular Ejection Function < 45%
- Systolic pulmonary arterial pressure > 45 mmHg
- History of pneumonectomy, lung surgery homolateral to the lobe targeted for endoscopic lung volume reduction
- History of pneumothorax homolateral to the lobe targeted for endoscopic lung volume reduction
- History of endoscopic volume reduction
- Oral corticosteroid therapy > 20 mg/day within the 4 weeks preceding inclusion
- Symptomatic bronchial dilatations, bronchial colonization with pseudomonas aeruginosa, multi-resistant bacteria or aspergillus origin
- Metastatic cancer undergoing treatment or whose treatments ended less than 5 years ago
- Pregnant or breastfeeding women
- Nickel allergy
- Patient under guardianship, curatorship or under judicial protection
- Participation in another interventional clinical research
- Any other condition which, in the opinion of the investigator, could interfere with the objective of the study or would cause the subject's participation in the study to be suboptimal, in particular (non-exhaustive list) unweaned alcoholism, substance abuse, non-compliance with usual follow-up visits)
- secondary exclusion criteria:
- Evidence of collateral ventilation measured by the Chartis system
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eloise DOBBELS, MD contact
17 sites in 1 country
France17 sites, 17 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Maéva ZYSMA, MD, maeva.zysman@chu-bordeaux.fr
Maéva ZYSMA, MD
- Recruiting
CHU de Brest
Brest, 29000
Christophe GUT-GOBERT, MD, christophe.gut-gobert@chubrest.fr
Christophe GUT-GOBERT, MD
- Not yet recruiting
Groupe Hospitalier Est - HCL
Bron, 69500
François LESTELLE, 04 27 85 77 00 ext. +33, francois.lestelle@chu-lyon.fr
François LESTELLE, MD
- Recruiting
CHU de Dijon
Dijon, 21000
Nicolas FAVROLT, MD, nicolas.favrolt@chu-dijon.fr
Nicolas FAVROLT, MD
- Recruiting
chu de Grenoble
Grenoble, 38000
amandine BRIAULT, MD, abriault@chu-grenoble.fr
amandine BRIAULT, MD
- Recruiting
CHU de Lille
Lille, 59000
Frederic WALLYN, MD, frederic.wallyn@chu-lille.fr
Frederic WALLYN, MD
- Recruiting
CHU de Limoges
Limoges, 87000
thomas EGENOD, MD, thomas.egenod@chu-limoges.fr
thomas egenod, MD
- Recruiting
APHM
Marseille, 13000
hervé DUTAU, MD, hdutau@ap-hm.fr
Hervé DUTAU, MD
- Recruiting
Hopital Saint Joseph
Marseille, 13000
Yoann AMMAR, MD, ammar.yoann@gmail.com
Yoann AMMAR, MD
- Not yet recruiting
CHU de Nice
Nice, 06000
Jacques BOUTROS, MD, boutros.j@chu-nice.fr
Jacques BOUTROS, MD
- Recruiting
APHP
Paris, 75018
Armelle MARCEAU, MD, armelle.marceau@bch.aphp
Armelle MARCEAU, MD
- Not yet recruiting
APHP
Paris, 78014
Christine LORUT, MD, christine.lorut@aphp.fr
Christine LORUT, MD
- Not yet recruiting
CHU de Rouen
Rouen, 76000
Samy LACHKAR, MD, samy.lachkar@churouen.fr
Samy LACHKAR, MD
- Recruiting
Hopital privé de la loire
Saint-Etienne, 42000
Antoine LUCHEZ, MD, 04 77 42 27 00 ext. +33, antoine.luchez@gmail.com
antoine LUCHEZ, MD
- Recruiting
chu de Strasbourg
Strasbourg, 67000
Romain KESSLER, MD, romain.kessler@chru-strasbourg.fr
Romain KESSLER, MD
- Recruiting
Hopital Foch
Suresnes, 92150
Olivier BRUGIERE, MD, o.brugiere@hopitalfoch.com
Olivier BRUGIERE, MD
- Recruiting
chu de Toulouse
Toulouse, 31000
nicolas GUIBERT, MD, guibert.n@chu-toulouse.fr
nicolas GUIBERT, MD
About this study
Official title: Randomized Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves
Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality.
Endoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation.
Read more
If this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event.
A new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment.
These data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.
Read the detailed description
The Zephyr® valve was first implanted in 2001. Since then, 5 important studies have proven a clinical superiority compared to the existing standard of care. Bronchoscopic lung-volume reduction with the use of one-way endobronchial valves is a potential treatment for patients with severe emphysema. Loss of lung elastic recoil leads to airflow obstruction, gas trapping, and increased operating lung volumes. Lung volume reduction surgery (LVRS), resection of the most affected of the lung, has been clearly shown to improve outcomes in selected patient groups. The surgical intervention is, however, associated with significant morbidity and an early mortality rate of about 5%. Therefore, there is considerable interest in developing novel treatment approaches that can reduce lung volume and gas trapping, either more safely than LVRS or in patients for whom LVRS is not an option.
In the present study, 244 patients will be randomized. After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. Half of them, the experimental group, will be treated according to Limoges' treatment algorithm (2 stages). For the other half, the control group, the entire lobe will be treated during one procedure will. Both groups will receive the standard of care treatments, according to the Global initiative for chronic Obstructive Lung Disease recommendations (GOLD).
Both groups will be followed for one year:
- All the patients will undergo a thorax CT scan 45 days after implanting the last valve. Three follow-up consultations are planned at 45 days, 6, and 12 months. During these consultations, each patient will complete a Saint-George Respiratory Questionnaire (SGRQ) Test, a plethysmography and a 6-minutes walking test.
- Patients randomized in the experimental group will undergo a plethysmography and a thorax CT scan one day before the second procedure.
- Conditions
- COPD
- Being tested
- Endoscopic lung volume reduction in 2 stages, Endoscopic lung volume reduction in 1 stage
- Keywords
- Endobronchial Zephyr® valves, Endoscopic lung volume reduction, Pneumothorax, Emphysema, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pneumothorax, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic lung volume reduction in 2 stagesProcedure or surgery
After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the experimental group, patients will be treated according to Limoges' treatment algorithm (2 stages)
Endoscopic lung volume reduction in 1 stageProcedure or surgery
After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the control group, the entire lobe will be treated during one procedure
| Study group | Role | What they receive |
|---|---|---|
| two-stage ZEPHYR® valves | Experimental | Not described Receives: Procedure: Endoscopic lung volume reduction in 2 stages |
| one-stage ZEPHYR® valves | Sham comparator | Not described Receives: Procedure: Endoscopic lung volume reduction in 1 stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax rate
Proportion of patients suffering from at least one pneumothorax rate between the beginning and the first 45 days following the end of lung volume reduction with ZEPHYR® valves
Measured: 45 day
Secondary outcomes (17)
Forced expiratory volume in one second (FEV1) measurement
Functional parameters at rest (plethysmography) - assessment of FEV1 in liter
Measured: 0 Day, 45 Day, 6 month and 12 month
Force Vital Expiratory (FVE) measurement
Functional parameters at rest (plethysmography) - assessment of FVE in Liter
Measured: 0 Day, 45 Day, 6 month and 12 month
Functional Residual Capacity (FRC) measurement
Functional parameters at rest (plethysmography) - assessment of FRC in Liter
Measured: 0 Day, 45 Day, 6 month and 12 month
Inspiratory Capacity (IC) measurement
Functional parameters at rest (plethysmography) - assessment of IC in Liter
Measured: 0 Day, 45 Day, 6 month and 12 month
Residual Volume (RV) measurement
Functional parameters at rest (plethysmography) - assessment of RV in Liter
Measured: 0 Day, 45 Day, 6 month and 12 month
Residual Volume (RV) / Total Lung Capacity (TLC) ratio
Functional parameters at rest (plethysmography) - assessment of ration RV/TLC in Liter
Measured: 0 Day, 45 Day, 6 month and 12 month
Exercise tolerance
6 minutes walking test
Measured: 0 Day, 45 Day, 6 month and 12 month
Quality of life questionnaire
EuroQol 5-Digit 5-level (EQ-5D-5L) questionnaire
Measured: 0 Day, 45 Day, 6 month and 12 month
Quality of life questionnaire
COPD Assessment Test (CAT). Minimum score is 0 and maximum is 40
Measured: 0 Day, 45 Day, 6 month and 12 month
Quality of life questionnaire
Saint-George Respiratory Questionnaire (SGRQ)
Measured: 0 Day, 45 Day, 6 month and 12 month
lobe volume reduction
Target lobe volume reduction by Thorax scanner
Measured: 45 Day
Respiratory events
Study of morbidity and mortality. number of Respiratory events
Measured: 12 month
Events related to the valves
Study of morbidity and mortality. number of events related to the valves
Measured: 12 month
Revision bronchoscopies
Study of morbidity and mortality. Numbers of revision bronchoscopies
Measured: 12 month
Death
Study of morbidity and mortality. numbers of death
Measured: 12 month
responder's rate
In the experimental arm, responder's rate after the first procedure (despite infralobar treatment) defined by:
- Plethysmography
- FEV1: Improvement of equal or more than 12%
- RV: Decrease of equal or more than 430mL
- Thorax CT scan: target lobe volume reduction rated at more than 350mL.
Measured: 12 month
Incremental Cost-Utility Ratio (ICUR)
Incremental Cost-Utility Ratio (ICUR) of the 2 intervention strategies expressed in euros per QALY gained in 12 months. The ICUR will be calculated on the basis of the following data:
Quality of life assessed by the EQ-5D-5L questionnaire. Direct medical costs.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start6 May 2024
- Primary completion6 Jun 2029 (estimated)
- Study completion6 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181357
- Sponsor's protocol ID
- 87RI21_0031 (REPEAT)
- Acronym
- REPEAT
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves
- ClinicalTrials.gov ID
- NCT06181357
- Acronym / sponsor ID
- REPEAT / 87RI21_0031 (REPEAT)
- Conditions
- COPD
- Keywords
- Endobronchial Zephyr® valves, Endoscopic lung volume reduction, Pneumothorax, Emphysema, COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 6 Jun 2029 (estimated)
- Study completion
- 6 Jun 2029 (estimated)
- First posted
- 26 Dec 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.
Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality.
Endoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation.
If this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event.
A new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment.
These data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.
Detailed description
The Zephyr® valve was first implanted in 2001. Since then, 5 important studies have proven a clinical superiority compared to the existing standard of care. Bronchoscopic lung-volume reduction with the use of one-way endobronchial valves is a potential treatment for patients with severe emphysema. Loss of lung elastic recoil leads to airflow obstruction, gas trapping, and increased operating lung volumes. Lung volume reduction surgery (LVRS), resection of the most affected of the lung, has been clearly shown to improve outcomes in selected patient groups. The surgical intervention is, however, associated with significant morbidity and an early mortality rate of about 5%. Therefore, there is considerable interest in developing novel treatment approaches that can reduce lung volume and gas trapping, either more safely than LVRS or in patients for whom LVRS is not an option.
In the present study, 244 patients will be randomized. After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. Half of them, the experimental group, will be treated according to Limoges' treatment algorithm (2 stages). For the other half, the control group, the entire lobe will be treated during one procedure will. Both groups will receive the standard of care treatments, according to the Global initiative for chronic Obstructive Lung Disease recommendations (GOLD).
Both groups will be followed for one year:
- All the patients will undergo a thorax CT scan 45 days after implanting the last valve. Three follow-up consultations are planned at 45 days, 6, and 12 months. During these consultations, each patient will complete a Saint-George Respiratory Questionnaire (SGRQ) Test, a plethysmography and a 6-minutes walking test.
- Patients randomized in the experimental group will undergo a plethysmography and a thorax CT scan one day before the second procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two-stage ZEPHYR® valves | Experimental | Procedure: Endoscopic lung volume reduction in 2 stages |
| one-stage ZEPHYR® valves | Sham comparator | Procedure: Endoscopic lung volume reduction in 1 stage |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient able to give informed consent and participate in the study
- Age ≥ 35 years old and ≤ 80 years old at the time of signing the consent
- Emphysema (homogeneous or heterogeneous) on a recent CT scan (< 6 months). Heterogeneous emphysema defined by a difference of at least 15% destruction (threshold 910HU) between two adjacent lobes.
- Destruction ≥ 50% (threshold 910 HU) of the target lobe on the chest scanner
- Smoking quit for 3 months
Key exclusion criteria (25 listed)
- Asthma considered as main diagnosis
- Recurrent exacerbations: (>3 over the last year or 2 requiring hospitalization)
- Myocardial infarction or stroke in the 6 months prior to inclusion
- Symptoms of heart failure in the 6 months prior to inclusion
- Chest CT abnormalities: giant bulla (occupying more than a third of the pulmonary field), paraseptal emphysema, pulmonary nodule greater than 0.8cm (not applicable pulmonary nodules known for more than a year and stable), fibrosing interstitial pneumonitis, dilated bronchi
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 |
|---|---|---|
| Endoscopic lung volume reduction in 2 stagesAfter the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the experimental group, patients will be treated according to Limoges' treatment algorithm (2 stages) | Procedure or surgery | two-stage ZEPHYR® valves |
| Endoscopic lung volume reduction in 1 stageAfter the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the control group, the entire lobe will be treated during one procedure | Procedure or surgery | one-stage ZEPHYR® valves |
Primary outcome
Pneumothorax rate
Time frame: 45 day
Proportion of patients suffering from at least one pneumothorax rate between the beginning and the first 45 days following the end of lung volume reduction with ZEPHYR® valves
17 secondary outcomes
Forced expiratory volume in one second (FEV1) measurement
Time frame: 0 Day, 45 Day, 6 month and 12 month
Force Vital Expiratory (FVE) measurement
Time frame: 0 Day, 45 Day, 6 month and 12 month
Functional Residual Capacity (FRC) measurement
Time frame: 0 Day, 45 Day, 6 month and 12 month
Inspiratory Capacity (IC) measurement
Time frame: 0 Day, 45 Day, 6 month and 12 month
Residual Volume (RV) measurement
Time frame: 0 Day, 45 Day, 6 month and 12 month
Residual Volume (RV) / Total Lung Capacity (TLC) ratio
Time frame: 0 Day, 45 Day, 6 month and 12 month
Exercise tolerance
Time frame: 0 Day, 45 Day, 6 month and 12 month
Quality of life questionnaire
Time frame: 0 Day, 45 Day, 6 month and 12 month
Quality of life questionnaire
Time frame: 0 Day, 45 Day, 6 month and 12 month
Quality of life questionnaire
Time frame: 0 Day, 45 Day, 6 month and 12 month
lobe volume reduction
Time frame: 45 Day
Respiratory events
Time frame: 12 month
Events related to the valves
Time frame: 12 month
Revision bronchoscopies
Time frame: 12 month
Death
Time frame: 12 month
responder's rate
Time frame: 12 month
Incremental Cost-Utility Ratio (ICUR)
Time frame: 12 month
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 23 Jun 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.
Eloise DOBBELS, MD contact
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic lung volume reduction in 2 stages and Endoscopic lung volume reduction in 1 stage in people with COPD, run by University Hospital, Limoges at 17 sites in France.
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 10 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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 Thomas EGENOD, MD (05 55 05 68 92, thomas.egenod@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumothorax rate (time frame: 45 day). 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 23 Jun 2026.