Pulmonary EmphysemaLIVENCT01580215
Long Term Follow up Investigation of Endobronchial Valves in Emphysema
An observational study of Pulmonary Emphysema, run by Pulmonx International Sàrl at 1 site in Germany.
Trial summary
This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Emphysema
- What is being tested?
- Zephyr Endobronchial Valve (EBV)
- Type of treatment
- Medical device
- How many people
- 628 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient participation is entirely voluntary. Patients must meet the inclusion/exlusion criteria to be eligible for the study.
Who may be able to join
- Patients of both genders of at least 18 years of age
- Understand and voluntarily sign an informed consent form.
- FEV1 > 15% predicted and < 45% predicted
- RV >180% predicted
- Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System
Who cannot join
- Active pulmonary infection
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.
Read the detailed description
Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.
- Conditions
- Pulmonary Emphysema
- Being tested
- Zephyr Endobronchial Valve (EBV)
- Keywords
- Valves, Endobronchial, Endoscopic lung volume reduction, Pulmonx, Zephyr, Chartis, Emphysema, COPD
- Medical subject headings
- Pulmonary Emphysema, 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 Valve (EBV)Device
- Implantation of at least one Zephyr EBV following Chartis assessment
| Study group | Role | What they receive |
|---|---|---|
| Main cohort | * Patients of both genders of at least 18 years of age
* Who understand and voluntarily sign an informed consent form
* FEV1 > 15% predicted and < 45% predicted
* RV >180% predicted
* Diagnosis of emphysema with CT evidence of hyperinflation
* Absence of collateral ventilation according to Chartis Assessment System
* Treated with Zephyr Endobronchial Valve (EBV) Receives: Device: Zephyr Endobronchial Valve (EBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)
Measured: 2 years
Secondary outcomes (3)
Modified Medical Research Council (mMRC) Questionnaire
Absolute and relative change from baseline at each visit over the 5 year period of the Modified Medical Research Council (mMRC) Score
Measured: 5 years
COPD Assessment Test (CAT)
Absolute and relative change from baseline at each visit over the 5-year period for the COPD Assessment Test (CAT)
Measured: 5 years
Survival over 5 years
Survival status over the 5 year study period
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Inability to reach desired recruitment goal; Sponsor executed other RCTs
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmonx International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix JF Herth, Prof. Dr., Principal investigator, Medizinische Fakultät Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580215
- Sponsor's protocol ID
- 630-0013
- Acronym
- LIVE
- Status last verified
- Dec 2017
- First submitted
- 17 Apr 2012
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up Investigation of Endobronchial Valves in Emphysema
- ClinicalTrials.gov ID
- NCT01580215
- Acronym / sponsor ID
- LIVE / 630-0013
- Conditions
- Pulmonary Emphysema
- Keywords
- Valves, Endobronchial, Endoscopic lung volume reduction, Pulmonx, Zephyr, Chartis, Emphysema, COPD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inability to reach desired recruitment goal; Sponsor executed other RCTs
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Pulmonx International SàrlIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Apr 2012 (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.
This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.
Detailed description
Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main cohort | – | Device: Zephyr Endobronchial Valve (EBV)* Patients of both genders of at least 18 years of age * Who understand and voluntarily sign an informed consent form * FEV1 > 15% predicted and < 45% predicted * RV >180% predicted * Diagnosis of emphysema with CT evidence of hyperinflation * Absence of collateral ventilation according to Chartis Assessment System * Treated with Zephyr Endobronchial Valve (EBV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient participation is entirely voluntary. Patients must meet the inclusion/exlusion criteria to be eligible for the study.
Key inclusion criteria (5 listed)
- Patients of both genders of at least 18 years of age
- Understand and voluntarily sign an informed consent form.
- FEV1 > 15% predicted and < 45% predicted
- RV >180% predicted
- Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System
Key exclusion criteria (1 listed)
- Active pulmonary infection
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 Valve (EBV)• Implantation of at least one Zephyr EBV following Chartis assessment | Device | Main cohort |
Primary outcome
FEV1
Time frame: 2 years
Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)
3 secondary outcomes
Modified Medical Research Council (mMRC) Questionnaire
Time frame: 5 years
COPD Assessment Test (CAT)
Time frame: 5 years
Survival over 5 years
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Inability to reach desired recruitment goal; Sponsor executed other RCTs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
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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, Prof. Dr. principal investigator
Medizinische Fakultät Heidelberg
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 Pulmonary Emphysema, run by Pulmonx International Sàrl 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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 26 Dec 2017. 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 was stopped early (reason given: Inability to reach desired recruitment goal; Sponsor executed other RCTs). Results are not available in the source record.
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?
FEV1 (time frame: 2 years). 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 26 Dec 2017.