EmphysemaPhase 1/2NCT01328899
Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)
A Phase 1/2 study testing Lung Volume Reduction Coil (LVRC) (PneumRx's) in people with Emphysema, run by Boston Scientific Corporation at 11 sites in 3 countries.
Trial summary
This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- Lung Volume Reduction Coil (LVRC) (PneumRx's)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Dec 2009to Jan 2013
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 35 years of age
- bilateral heterogenous 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 significant respirator 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 clinical significant bronchiectasis
- Patient has had previous LVR surgery, lung transplant or lobectomy
- Patient has been involved in other pulmonary drug studies within 30 days prior to this study
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Germany7 sites
Campus Charite Mitte
Berlin
Klinikum Donaustauf
Donaustauf
Asklepios
Gauting
Thoraxklinik
Heidelberg
Lungenklinik
Hemer
Krankenhaus von Roten Kreuz
Stuttgart
UKT University Hospital
Teubingen
France3 sites
CHU de Nice - Hospital Pasteur
Nice
Gaetan Deslee
Reims
CHRU de Strasbourg-NHC
Strasbourg
About this study
Official title: Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.
- Conditions
- Emphysema
- Being tested
- Lung Volume Reduction Coil (LVRC) (PneumRx's)
- Keywords
- Emphysema, COPD, RePneu
- 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.
Lung Volume Reduction Coil (LVRC) (PneumRx's)Device
Also called Lung Volume Reduction Device (LVRD)
Lung Volume Reduction Coil
| Study group | Role | What they receive |
|---|---|---|
| Lung Volume Reduction Coil (LVRC) | Experimental | Lung Volume Reduction Coil (LVRC) Receives: Device: Lung Volume Reduction Coil (LVRC) (PneumRx's) |
What is being measured
The primary outcome is the main question the study is designed to answer.
St. George's Respiratory Questionnaire
Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline
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 posted5 Apr 2011 (estimated)
- Study startDec 2009
- Primary completionJan 2013
- Study completionJan 2013
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328899
- Sponsor's protocol ID
- CLN0011
- Status last verified
- Jul 2021
- First submitted
- 1 Apr 2011
- Last updated
- 21 Jul 2021
- 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 25418910Deslee G, Klooster K, Hetzel M, Stanzel F, Kessler R, Marquette CH, Witt C, Blaas S, Gesierich W, Herth FJ, Hetzel J, van Rikxoort EM, Slebos DJ. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial. Thorax. 2014 Nov;69(11):980-6. doi: 10.1136/thoraxjnl-2014-205221. Epub 2014 Jun 2.
PubMed 24891327
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
- ClinicalTrials.gov ID
- NCT01328899
- Acronym / sponsor ID
- CLN0011
- Conditions
- Emphysema
- Keywords
- Emphysema, COPD, RePneu
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- Dec 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Apr 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.
This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Volume Reduction Coil (LVRC) | Experimental | Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)Lung Volume Reduction Coil (LVRC) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than or equal to 35 years of age
- bilateral heterogenous emphysema
- Patient has stopped smoking for a minimum of 8 weeks
- Read, understood and signed the Informed consent form
Key exclusion criteria (7 listed)
- Patient has a history of recurrent significant respirator 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 clinical 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) (PneumRx's)Also: Lung Volume Reduction Device (LVRD)Lung Volume Reduction Coil | Device | Lung Volume Reduction Coil (LVRC) |
Primary outcome
St. George's Respiratory Questionnaire
Time frame: 6 months
Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline
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 21 Jul 2021.
- 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 24891327Deslee G, Klooster K, Hetzel M, Stanzel F, Kessler R, Marquette CH, Witt C, Blaas S, Gesierich W, Herth FJ, Hetzel J, van Rikxoort EM, Slebos DJ. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial. Thorax. 2014 Nov;69(11):980-6. doi: 10.1136/thoraxjnl-2014-205221. Epub 2014 Jun 2.
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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.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lung Volume Reduction Coil (LVRC) (PneumRx's) in people with Emphysema, run by Boston Scientific Corporation at 11 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 4 inclusion and 7 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, France, 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
St. George's Respiratory Questionnaire (time frame: 6 months). 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 NCT01328899, 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 21 Jul 2021.