EmphysemaNCT01806636
Post Market Observational, Prospective, Multi-center Study
An observational study of Emphysema, run by Boston Scientific Corporation at 73 sites in 6 countries.
Trial summary
This registry is a post market observational, prospective, multi-center registry. It is designed to evaluate patient experience with the endobronchial coil system for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- PneumRx Coil System
- Type of treatment
- Medical device
- How many people
- 1,275 participants
- Where
- 73 sitesin 6 countries
- Study dates
- May 2013to Jul 2019
- How long will I take part?
- 3 Years
- 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: All adult patients diagnosed with homogeneous or heterogeneous emphysema who are appropriate for Coil treatment based on the CE-Mark Approved IFU and who have been scheduled for treatment with the RePneu procedure will be eligible to participate in the Registry. If they agree and sign a consent form, they will then become study participants.
Inclusion and exclusion criteria in the Registry are based on CE Mark approved indication and approved Instructions for Use. Patients enrolled and treated in the Registry study should meet the requirements of the PneumRx Endobronchial Coil System Instructions for Use.
Trial locations and contacts
73 sites in 6 countries.
73 sites in 6 countries
Germany51 sites
Hochtaunus-Kliniken, Klinik für Pneumolog und Onkologie
Bad Homburg, 61352
Charité Campus Mitte
Berlin, 10117
Charité Campus Virchow-Klinikum
Berlin, 13353
Gemeinschaftskrankenhaus Havelhöhe
Berlin, 14089
Helios Klinikum Emil von Behring, Berlin
Berlin-Zehlendorf, 14165
Universitätsklinikum Bonn
Bonn, 53105
Ev. Krankenhaus Göttingen-Weende
Bovenden, 37120
DRK Klinik am Bürgerpark
Bremerhaven, 27574
Kreiskliniken Altötting-Burghausen
Burghausen, 84489
St. Marien-Hospital
Cologne, 50668
Schwarzwald-Baar-Klinikum
Donaueschingen, 78166
Klinik Donaustauf
Donaustauf, 93093
Medizinische Klinik Nord
Dortmund, 44145
HELIOS Klinikum Duisburg
Duisburg, 47166
Johanniter KH Duisburg Rheinhausen
Duisburg, 47228
Pneumologische Klinik Waldhof Elgershausen
Elgershausen, 35753
Ruhrlandklinik
Essen, 45239
Bethanien Krankenhaus
Frankfurt am Main, 60487
St. Elisabethen Krankenhaus
Frankfurt am Main, 60487
Klinikum Fürth
Fürth, 90766
Asklepios-Klinikum Gauting
Gauting, 82131
SRH Wald-Klinikum Gera GmbH
Gera, 07548
Universitätsmedizin Greifswald
Greifswald, 17475
Universitätsklinikum Halle
Halle, 06120
Diakoniekrankenhaus Halle
Halle, 6114
Uniklinik Eppendorf
Hamburg, 20246
Asklepios Klinik Barmbeck
Hamburg, 22291
Asklepios
Harburg, 21075
Lungenklinik
Hemer, 58675
Lungenfachklinik Immenhausen
Immenhausen, 34376
Klinikverbund Kempten-Oberallgäu
Kempten, 87439
Marienhof Koblenz
Koblenz, 56073
HELIOS Klinikum Krefeld
Krefeld, 47805
Lungenklinik Lostau
Lostau, 39291
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
Universitätsklinikum Magdeburg
Magdeburg, 39120
Katholisches Klinikum Mainz
Mainz, 55131
Krankenhaus Martha-Maria
München, 81479
Städt. Klinikum München-Harlaching
München, 81545
Städt. Klinikum München-Bogenhausen
München, 81925
Ruppiner Kliniken GmbH
Neuruppin, 16816
Brüderkrankenhaus St. Josef Paderborn
Paderborn, 33098
Universitätsklinikum
Regensburg, 93053
RoMed Klinikum Rosenheim
Rosenheim, 83022
Helios Kliniken Schwerin
Schwerin, 19049
Krankenhaus Bethanien Solingen
Solingen, 42699
Krankenhaus vom Roten Kreuz
Stuttgart, 70372
Universitätsklinikum Ulm
Ulm, 89081
Saarland Heilstätten GmbH
Völklingen, 66333
Petrus-Krankenhaus
Wuppertal, 42282
Medizinisches Zentrum Städte Region Aachen GmbH
Würselen, 52146
Switzerland7 sites
Inselspital
Bern, CH-3010
Hôpitaux Universitaires de Genève (HUG)
Geneva, 1211
CHUV
Lausanne, 1011
L'hôpital Neuchâtelois - Pourtalès
Neuchâtel, 2000
Kantonsspital Sankt Gallen
Sankt Gallen, 9007
Lungenzentrum Hirslanden
Zurich, 8032
UniversitätsSpital Zürich
Zurich, 8091
United Kingdom7 sites
Heartlands Birmingham
Birmingham, B9 4 LS
Bristol Royal Infirmary
Bristol, BS2 8HW
Leicester Royal Infirmary
Leicester, LE1 5WW
Guy's and St Thomas' Hospital
London, SE1 9RT
Royal Brompton Hospital
London, SW3 6NP
Royal Preston Hospital
Preston, PR2 9HT
Southampton General Hospital
Southampton, SO16 6YD
Spain6 sites
Centro Médico Teknon
Barcelona
Hospital de Basurto
Bilbao
Hospital Universitario Quirón
Madrid, 28223
Fundación Jiménez Díaz
Madrid
Hospital Quiron
Málaga
Hospital Universitario y Politécnico La Fe
Valencia, 46026
About this study
Official title: Post Market Observational, Prospective, Multi-center Registry Using the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) System
This registry is a post market observational, prospective, multi-center registry.
It is designed to evaluate patient experience with the endobronchial coil system for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product.
- Conditions
- Emphysema
- Being tested
- PneumRx Coil System
- Keywords
- Coil, RePneu, PneumRx, LVRC
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumRx Coil SystemDevice
Also called RePneu, LVRC
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Patients treated with PneumRx Coil System Receives: Device: PneumRx Coil System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Quality of Life (QOL) measures
Measured: 6 months and yearly up to three years post treatment 1
Secondary outcomes (2)
Changes in Pulmonary Function and Exercise Capacity test results
Measured: 6 months and yearly up to three years post treatment 1
Safety including any device malfunction or failure(s)
Measured: 6 months and yearly up to three years post treatment 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,275 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Martin Hetzel, Prof., Principal investigator, Krankenhaus vom Roten KreuzChristian Schumann, MD, Principal investigator, Klinikenverbund Kempten-Oberallgäu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806636
- Sponsor's protocol ID
- CLN0014
- Status last verified
- Jul 2021
- First submitted
- 17 Feb 2013
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Observational, Prospective, Multi-center Registry Using the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) System
- ClinicalTrials.gov ID
- NCT01806636
- Acronym / sponsor ID
- CLN0014
- Conditions
- Emphysema
- Keywords
- Coil, RePneu, PneumRx, LVRC
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,275 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- PneumRx, Inc.
- Study start
- May 2013
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Mar 2013 (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 registry is a post market observational, prospective, multi-center registry.
It is designed to evaluate patient experience with the endobronchial coil system for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: PneumRx Coil SystemPatients treated with PneumRx Coil System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients diagnosed with homogeneous or heterogeneous emphysema who are appropriate for Coil treatment based on the CE-Mark Approved IFU and who have been scheduled for treatment with the RePneu procedure will be eligible to participate in the Registry. If they agree and sign a consent form, they will then become study participants.
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 |
|---|---|---|
| PneumRx Coil SystemAlso: RePneu, LVRC | Device | Treatment |
Primary outcome
Changes in Quality of Life (QOL) measures
Time frame: 6 months and yearly up to three years post treatment 1
2 secondary outcomes
Changes in Pulmonary Function and Exercise Capacity test results
Time frame: 6 months and yearly up to three years post treatment 1
Safety including any device malfunction or failure(s)
Time frame: 6 months and yearly up to three years post treatment 1
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
Related trials for Emphysema
RecruitingEarly Phase 1
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
Air Trapping, Emphysema
RecruitingPhase 4
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
Alpha 1-Antitrypsin, COPD
Enrolling by invitationObservational study
AATD-Liver Scan Study
Alpha-1 Antitrypsin Deficiency, AATD
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
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.
Martin Hetzel, Prof. principal investigator
Krankenhaus vom Roten Kreuz
Christian Schumann, MD principal investigator
Klinikenverbund Kempten-Oberallgäu
73 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emphysema, run by Boston Scientific Corporation at 73 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 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 73 sites in Germany, Switzerland, United Kingdom, Spain, Austria and 1 more country. 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. 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?
Changes in Quality of Life (QOL) measures (time frame: 6 months and yearly up to three years post treatment 1). 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 16 Jul 2021.