Pulmonary EmphysemaNCT04161235
Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV
An observational study of Pulmonary Emphysema, run by Pulmonx Corporation at 3 sites in 3 countries.
Trial summary
This is a Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess Treated Lobar Volume Reduction (TLVR), changes in lung function and the safety profile of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV. 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?
- The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Feb 2020to 30 Dec 2021
- How long will I take part?
- 3 Months
- 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: The population evaluated will comprise of patients with hyperinflation associated with severe emphysema that are considered appropriate for the procedure by their physician, confirmed to have little to no collateral ventilation and had at least one Zephyr Valve 5.5-LP EBV implanted during the procedure.
Who may be able to join
- Patients with severe emphysema prescribed treatment with Zephyr Valves
- Zephyr Valve Treatment with the use of at least one Zephyr Valve 5.5-LP EBV
Who cannot join
- Patients determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
- Patients who undergo Zephyr Valve treatment, but no Zephyr Valve 5.5-LP EBV implanted.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV for Bronchoscopic Lung Volume Reduction (BLVR) Procedures
This is a Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess Treated Lobar Volume Reduction (TLVR), changes in lung function and the safety profile of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.
Read the detailed description
This is a multi-center, single-arm, prospective, observational study. Approximately 70 study participants undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV will be enrolled and followed out to 3 months. Assessments will be conducted at 45 days and 3 months. The evaluation will be conducted at up to 6 sites.
Patients prescribed Zephyr Valve treatment for their emphysema will be consented and will be enrolled only after: 1) determination of little to no collateral ventilation between target and ipsilateral lobes and 2) implantation of at least one Zephyr Valve 5.5-LP EBV. Baseline data will be collected retrospectively after enrollment of a patient in the Post-Market Evaluation. Performance and safety of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP will be evaluated post-treatment based on data collected until 3 months after the treatment.
- Conditions
- Pulmonary Emphysema
- Being tested
- The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP
- Medical subject headings
- Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LPDevice
The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV. Receives: Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treated Lobar Volume Reduction (TLVR) responders
The percentage of patients treated with the Zephyr Valve 5.5-LP EBV who achieved a Treated Lobar Volume Reduction (TLVR) of the treated lobe (s) of ≥350ml as seen via HRCT at 45-days.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start5 Feb 2020
- Primary completion13 Aug 2021
- Study completion30 Dec 2021
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
- 2 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Pulmonx Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161235
- Sponsor's protocol ID
- 630-0025-01
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2019
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV for Bronchoscopic Lung Volume Reduction (BLVR) Procedures
- ClinicalTrials.gov ID
- NCT04161235
- Acronym / sponsor ID
- 630-0025-01
- Conditions
- Pulmonary Emphysema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Pulmonx CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 13 Nov 2019 (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.
This is a Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess Treated Lobar Volume Reduction (TLVR), changes in lung function and the safety profile of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.
Detailed description
This is a multi-center, single-arm, prospective, observational study. Approximately 70 study participants undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV will be enrolled and followed out to 3 months. Assessments will be conducted at 45 days and 3 months. The evaluation will be conducted at up to 6 sites.
Patients prescribed Zephyr Valve treatment for their emphysema will be consented and will be enrolled only after: 1) determination of little to no collateral ventilation between target and ipsilateral lobes and 2) implantation of at least one Zephyr Valve 5.5-LP EBV. Baseline data will be collected retrospectively after enrollment of a patient in the Post-Market Evaluation. Performance and safety of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP will be evaluated post-treatment based on data collected until 3 months after the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LPPatients undergoing Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population evaluated will comprise of patients with hyperinflation associated with severe emphysema that are considered appropriate for the procedure by their physician, confirmed to have little to no collateral ventilation and had at least one Zephyr Valve 5.5-LP EBV implanted during the procedure.
Key inclusion criteria (2 listed)
- Patients with severe emphysema prescribed treatment with Zephyr Valves
- Zephyr Valve Treatment with the use of at least one Zephyr Valve 5.5-LP EBV
Key exclusion criteria (2 listed)
- Patients determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
- Patients who undergo Zephyr Valve treatment, but no Zephyr Valve 5.5-LP EBV implanted.
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 |
|---|---|---|
| The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LPThe Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks. | Device | Treatment |
Primary outcome
Treated Lobar Volume Reduction (TLVR) responders
Time frame: 45 days
The percentage of patients treated with the Zephyr Valve 5.5-LP EBV who achieved a Treated Lobar Volume Reduction (TLVR) of the treated lobe (s) of ≥350ml as seen via HRCT at 45-days.
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 15 Nov 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: 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 Corporation at 3 sites in 3 countries.
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 2 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 15 Nov 2023. 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, Switzerland, United Kingdom. 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?
Treated Lobar Volume Reduction (TLVR) responders (time frame: 45 days). 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 15 Nov 2023.