EmphysemaPhase 3NCT00613860
Sequential Endoscopic Lung Volume Reduction
A Phase 3 study testing Zephyr endobronchial valve in people with Emphysema and COPD, run by Heidelberg University at 3 sites in Germany.
Trial summary
Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- Zephyr endobronchial valve
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2008to Apr 2012
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heterogenous emphysema
- FEV1 < 45%
- RV > 150%
- TLC > 100%
- TLCO < 40%
Who cannot join
- Homogeneous emphysema
- Pregnancy
- PCO2 > 50 mmHg
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Charite, University of Berlin
Berlin, 10117
Thoraxklinik, University of Heidelberg
Heidelberg, 69190
Medical Center Nürnberg
Nuremberg, 90340
About this study
Official title: Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema
Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.
Read the detailed description
Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too.
Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30
- Being tested
- Zephyr endobronchial valve
- Keywords
- Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy
- 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.
Zephyr endobronchial valveDevice
Endobronchial valve system to redirect the airflow within the bronchial system
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV 1 6 Minute walk test
Measured: 6 months after intervention
Secondary outcomes (1)
Safety Symptom scores
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011 (estimated)
- Study completionApr 2012
Why it stopped: complicated patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
- Investigators
- Felix JF Herth, MD, PhD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613860
- Sponsor's protocol ID
- 02/08
- Status last verified
- Aug 2022
- First submitted
- 31 Jan 2008
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Strange C, Herth FJ, Kovitz KL, McLennan G, Ernst A, Goldin J, Noppen M, Criner GJ, Sciurba FC; VENT Study Group. Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction. BMC Pulm Med. 2007 Jul 3;7:10. doi: 10.1186/1471-2466-7-10.
PubMed 17711594de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190.
PubMed 16840401Venuta F, de Giacomo T, Rendina EA, Ciccone AM, Diso D, Perrone A, Parola D, Anile M, Coloni GF. Bronchoscopic lung-volume reduction with one-way valves in patients with heterogenous emphysema. Ann Thorac Surg. 2005 Feb;79(2):411-6; discussion 416-7. doi: 10.1016/j.athoracsur.2004.07.048.
PubMed 15680805Yim AP, Hwong TM, Lee TW, Li WW, Lam S, Yeung TK, Hui DS, Ko FW, Sihoe AD, Thung KH, Arifi AA. Early results of endoscopic lung volume reduction for emphysema. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1564-73. doi: 10.1016/j.jtcvs.2003.10.005.
PubMed 15173708Shah PL, Gompelmann D, Valipour A, McNulty WH, Eberhardt R, Grah C, Egan J, Ficker JH, Wagner M, Witt C, Liebers U, Hopkins P, Gesierich W, Phillips M, Stanzel F, Petermann C, Strange C, Snell G, Herth FJF. Thermal vapour ablation to reduce segmental volume in patients with severe emphysema: STEP-UP 12 month results. Lancet Respir Med. 2016 Sep;4(9):e44-e45. doi: 10.1016/S2213-2600(16)30199-0. Epub 2016 Jul 20. No abstract available.
PubMed 27451345
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Endoscopic Lung Volume Reduction in Patients With Heterogeneous Lung Emphysema
- ClinicalTrials.gov ID
- NCT00613860
- Acronym / sponsor ID
- 02/08
- Keywords
- Endoscopic lung volume reduction, heterogeneous emphysema, interventional bronchoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: complicated patient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Humboldt-Universität zu Berlin
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Feb 2008 (estimated)
- 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.
Patients with heterogenous emphysema benefits from endoscopic lung volume reduction. Until now the technique is limited to one lobe. In case of collateral ventilation patients show no improvement. Between upper and middle lobe exists the highest collateral flow. The trial examine the hypothesis, that sequential ELVR help especially those patients, which have no benefit after lobar exclusion.
Detailed description
Patients with heterogenous emphysema undergo ELVR, target lobe is the upper lobe right. After 6 weeks the middle lobe will be block too.
Follow-up period 6 months Primary end points: FEV 1, 6-Minute walk test Secondary endpoints. Safety, Symptom scores Number of patients planned 30
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Heterogenous emphysema
- FEV1 < 45%
- RV > 150%
- TLC > 100%
- TLCO < 40%
Key exclusion criteria (3 listed)
- Homogeneous emphysema
- Pregnancy
- PCO2 > 50 mmHg
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 |
|---|---|---|
| Zephyr endobronchial valveEndobronchial valve system to redirect the airflow within the bronchial system | Device | – |
Primary outcome
FEV 1 6 Minute walk test
Time frame: 6 months after intervention
1 secondary outcome
Safety Symptom scores
Time frame: 6 months after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 17711594Strange C, Herth FJ, Kovitz KL, McLennan G, Ernst A, Goldin J, Noppen M, Criner GJ, Sciurba FC; VENT Study Group. Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction. BMC Pulm Med. 2007 Jul 3;7:10. doi: 10.1186/1471-2466-7-10.
- Background: PubMed 16840401de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190.
- Background: PubMed 15680805Venuta F, de Giacomo T, Rendina EA, Ciccone AM, Diso D, Perrone A, Parola D, Anile M, Coloni GF. Bronchoscopic lung-volume reduction with one-way valves in patients with heterogenous emphysema. Ann Thorac Surg. 2005 Feb;79(2):411-6; discussion 416-7. doi: 10.1016/j.athoracsur.2004.07.048.
- Background: PubMed 15173708Yim AP, Hwong TM, Lee TW, Li WW, Lam S, Yeung TK, Hui DS, Ko FW, Sihoe AD, Thung KH, Arifi AA. Early results of endoscopic lung volume reduction for emphysema. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1564-73. doi: 10.1016/j.jtcvs.2003.10.005.
- Results publication: PubMed 27451345Shah PL, Gompelmann D, Valipour A, McNulty WH, Eberhardt R, Grah C, Egan J, Ficker JH, Wagner M, Witt C, Liebers U, Hopkins P, Gesierich W, Phillips M, Stanzel F, Petermann C, Strange C, Snell G, Herth FJF. Thermal vapour ablation to reduce segmental volume in patients with severe emphysema: STEP-UP 12 month results. Lancet Respir Med. 2016 Sep;4(9):e44-e45. doi: 10.1016/S2213-2600(16)30199-0. Epub 2016 Jul 20. No abstract available.
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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.
Felix JF Herth, MD, PhD principal investigator
Heidelberg University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zephyr endobronchial valve in people with Emphysema and COPD, run by Heidelberg University at 3 sites in Germany.
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 3 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: withdrawn, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
FEV 1 6 Minute walk test (time frame: 6 months after intervention). 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 NCT00613860, which also lists 5 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 2 Sep 2022; AzTrials last refreshed its copy on 28 Oct 2026.