Pulmonary EmphysemaNCT01457833
Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema
A study testing EBV implantation and IBV implantation in people with Pulmonary Emphysema, run by Heidelberg University at 1 site in Germany.
Trial summary
Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pulmonary Emphysema
- What is being tested?
- EBV implantation and IBV implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to 1 May 2012
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
- heterogeneous emphysema
Who cannot join
- homogeneous emphysema
- significant bronchiectasis
- severe concomitant diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema
Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.
Read the detailed description
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.
- Conditions
- Pulmonary Emphysema
- Being tested
- EBV implantation, IBV implantation
- Medical subject headings
- Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV implantationDevice
Also called (Zephyr EBV)
In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.
IBV implantationDevice
Also called (Spiration IBV)
In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.
| Study group | Role | What they receive |
|---|---|---|
| Endobronchial valves (EBV) | Active comparator | Complete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves Receives: Device: EBV implantation |
| Intrabronchial valves (IBV) | Active comparator | Complete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves Receives: Device: IBV implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pulmonary function (FEV1 and RV/TLC)
Measured: 6 months
Secondary outcomes (4)
Number of severe adverse events
Measured: 6 months
Evaluation of valve migration rate
Measured: 6 months
Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)
Measured: 6 months
Average changes in 6-minute-walk-distance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startAug 2011
- Primary completion1 May 2012
- Study completion1 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix JF Herth, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457833
- Sponsor's protocol ID
- Protokoll E1.0-23.05.2011
- Status last verified
- Jul 2022
- First submitted
- 19 Oct 2011
- Last updated
- 7 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Lung Volume Reduction by Implantation of Endobronchial Valves (EBV) vs. Intrabronchial Valves (IBV) in Patients With Severe Heterogeneous Emphysema
- ClinicalTrials.gov ID
- NCT01457833
- Acronym / sponsor ID
- Protokoll E1.0-23.05.2011
- Conditions
- Pulmonary Emphysema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- 1 May 2012 (actual)
- Study completion
- 1 May 2012 (actual)
- First posted
- 24 Oct 2011 (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 advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.
Detailed description
Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endobronchial valves (EBV) | Active comparator | Device: EBV implantationComplete occlusion of one emphysematous destroyed lobe by implantation of endobronchial valves |
| Intrabronchial valves (IBV) | Active comparator | Device: IBV implantationComplete occlusion of one emphysematous destroyed lobe by implantation of intrabronchial valves |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
- heterogeneous emphysema
Key exclusion criteria (4 listed)
- homogeneous emphysema
- significant bronchiectasis
- severe concomitant diseases
- pregnancy
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 |
|---|---|---|
| EBV implantationAlso: (Zephyr EBV)In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration. | Device | Endobronchial valves (EBV) |
| IBV implantationAlso: (Spiration IBV)In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration. | Device | Intrabronchial valves (IBV) |
Primary outcome
Improvement in pulmonary function (FEV1 and RV/TLC)
Time frame: 6 months
4 secondary outcomes
Number of severe adverse events
Time frame: 6 months
Evaluation of valve migration rate
Time frame: 6 months
Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)
Time frame: 6 months
Average changes in 6-minute-walk-distance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBV implantation and IBV implantation in people with Pulmonary Emphysema, run by Heidelberg University at 1 site 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 7 Jul 2022. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in pulmonary function (FEV1 and RV/TLC) (time frame: 6 months). 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 7 Jul 2022.