EmphysemaNCT01220908
Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema
A study testing Lung Volume Reduction Coil (LVRC) and Coils in people with Emphysema, run by Boston Scientific Corporation at 5 sites in 2 countries.
Trial summary
The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. Read more about this study
- Who is it for?
- Ages 35 to 100 years
- Conditions the study is for
- Emphysema
- What is being tested?
- Lung Volume Reduction Coil (LVRC) and Coils
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2008to Mar 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 35 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > 35 years of age
- unilateral or bilateral emphysema
- Patient has stopped smoking for a minimum of 8 weeks
- Read, understood and signed the Informed Consent form
Who cannot join
- Patient has a history of recurrent clinically significant respiratory infection
- Patient has an inability to walk >140 meters
- Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
- Patient is pregnant or lactating
- Patient has clinically significant bronchiectasis
- Patient has had previous LVR surgery, lung transplant or lobectomy
- Patient has been involved in other pulmonary drug studies with 30 days prior to this study
- Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Klinikum Donaustauf
Donaustauf
Asklepios
Gauting
Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
Heidelberg
Lungenklinik
Hemer
Netherlands1 site
University Medical Center Groningen
Groningen, 3150-3610536
About this study
Official title: Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.
- Conditions
- Emphysema
- Being tested
- Lung Volume Reduction Coil (LVRC), Coils
- Keywords
- LVRS (Lung Volume Reduction Surgery), LVRC (Lung Volume Reduction Coil), Emphysema, coil, RePneu
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Volume Reduction Coil (LVRC)Device
Also called Lung Volume Reduction Surgery (LVRS), Lobectomy
Implantation of Lung Volume Reduction Coil(s) (LVRC)
CoilsDevice
Also called Lung Volume Reduction Surgery (LVRS), Lobectomy
Lung Volume Reduction Coil(s)
| Study group | Role | What they receive |
|---|---|---|
| permanent Coil(s) implant, QOL measure | Experimental | Coil implantation as treatment. Treatment is permanent implant. Receives: Device: Lung Volume Reduction Coil (LVRC); Device: Coils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Assessment.
Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)
Measured: Three + Months Follow-Up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startJan 2008
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Dirk-Jan Slebos, MD, PhD, Principal investigator, University Medical Center GroningenProf. Felix JF Herth, MD, PhD, Principal investigator, Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220908
- Sponsor's protocol ID
- CLN0006
- Status last verified
- May 2023
- First submitted
- 30 Sep 2010
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Hartman JE, Klooster K, Gortzak K, ten Hacken NH, Slebos DJ. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015 Feb;20(2):319-26. doi: 10.1111/resp.12435. Epub 2014 Nov 23.
PubMed 25418910Slebos DJ, Klooster K, Ernst A, Herth FJF, Kerstjens HAM. Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema. Chest. 2012 Sep;142(3):574-582. doi: 10.1378/chest.11-0730.
PubMed 22116796
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
- ClinicalTrials.gov ID
- NCT01220908
- Acronym / sponsor ID
- CLN0006
- Conditions
- Emphysema
- Keywords
- LVRS (Lung Volume Reduction Surgery), LVRC (Lung Volume Reduction Coil), Emphysema, coil, RePneu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- Jan 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Oct 2010 (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.
The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| permanent Coil(s) implant, QOL measure | Experimental | Device: Lung Volume Reduction Coil (LVRC), Device: CoilsCoil implantation as treatment. Treatment is permanent implant. |
Who may qualify
- Ages
- 35 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient > 35 years of age
- unilateral or bilateral emphysema
- Patient has stopped smoking for a minimum of 8 weeks
- Read, understood and signed the Informed Consent form
Key exclusion criteria (8 listed)
- Patient has a history of recurrent clinically significant respiratory infection
- Patient has an inability to walk >140 meters
- Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
- Patient is pregnant or lactating
- Patient has clinically significant bronchiectasis
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 |
|---|---|---|
| Lung Volume Reduction Coil (LVRC)Also: Lung Volume Reduction Surgery (LVRS), LobectomyImplantation of Lung Volume Reduction Coil(s) (LVRC) | Device | permanent Coil(s) implant, QOL measure |
| CoilsAlso: Lung Volume Reduction Surgery (LVRS), LobectomyLung Volume Reduction Coil(s) | Device | permanent Coil(s) implant, QOL measure |
Primary outcome
Quality of Life Assessment.
Time frame: Three + Months Follow-Up Visit
Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)
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 11 May 2023.
- Derived from this study: PubMed 25418910Hartman JE, Klooster K, Gortzak K, ten Hacken NH, Slebos DJ. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015 Feb;20(2):319-26. doi: 10.1111/resp.12435. Epub 2014 Nov 23.
- Derived from this study: PubMed 22116796Slebos DJ, Klooster K, Ernst A, Herth FJF, Kerstjens HAM. Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema. Chest. 2012 Sep;142(3):574-582. doi: 10.1378/chest.11-0730.
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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.
Dirk-Jan Slebos, MD, PhD principal investigator
University Medical Center Groningen
Prof. Felix JF Herth, MD, PhD principal investigator
Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Volume Reduction Coil (LVRC) and Coils in people with Emphysema, run by Boston Scientific Corporation at 5 sites in 2 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 4 inclusion and 8 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Netherlands. 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?
Quality of Life Assessment. (time frame: Three + Months Follow-Up Visit). 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 NCT01220908, which also lists 2 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 11 May 2023.