Post Market Observational, Prospective, Multi-center Study
1 other identifier
observational
1,275
6 countries
73
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJuly 16, 2021
July 1, 2021
6.2 years
February 17, 2013
July 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Quality of Life (QOL) measures
6 months and yearly up to three years post treatment 1
Secondary Outcomes (2)
Changes in Pulmonary Function and Exercise Capacity test results
6 months and yearly up to three years post treatment 1
Safety including any device malfunction or failure(s)
6 months and yearly up to three years post treatment 1
Study Arms (1)
Treatment
Patients treated with PneumRx Coil System
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- PneumRx, Inc.collaborator
Study Sites (73)
Otto-Wagner-Spital
Vienna, 1140, Austria
Rigshospitalet Copenhaven
Copenhagen, 2100, Denmark
Hochtaunus-Kliniken, Klinik für Pneumolog und Onkologie
Bad Homburg, 61352, Germany
Charité Campus Mitte
Berlin, 10117, Germany
Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
Gemeinschaftskrankenhaus Havelhöhe
Berlin, 14089, Germany
Helios Klinikum Emil von Behring, Berlin
Berlin-Zehlendorf, 14165, Germany
Universitätsklinikum Bonn
Bonn, 53105, Germany
Ev. Krankenhaus Göttingen-Weende
Bovenden, 37120, Germany
DRK Klinik am Bürgerpark
Bremerhaven, 27574, Germany
Kreiskliniken Altötting-Burghausen
Burghausen, 84489, Germany
St. Marien-Hospital
Cologne, 50668, Germany
Schwarzwald-Baar-Klinikum
Donaueschingen, 78166, Germany
Klinik Donaustauf
Donaustauf, 93093, Germany
Medizinische Klinik Nord
Dortmund, 44145, Germany
HELIOS Klinikum Duisburg
Duisburg, 47166, Germany
Johanniter KH Duisburg Rheinhausen
Duisburg, 47228, Germany
Pneumologische Klinik Waldhof Elgershausen
Elgershausen, 35753, Germany
Ruhrlandklinik
Essen, 45239, Germany
Bethanien Krankenhaus
Frankfurt am Main, 60487, Germany
St. Elisabethen Krankenhaus
Frankfurt am Main, 60487, Germany
Klinikum Fürth
Fürth, 90766, Germany
Asklepios-Klinikum Gauting
Gauting, 82131, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Universitätsmedizin Greifswald
Greifswald, 17475, Germany
Universitätsklinikum Halle
Halle, 06120, Germany
Diakoniekrankenhaus Halle
Halle, 6114, Germany
Uniklinik Eppendorf
Hamburg, 20246, Germany
Asklepios Klinik Barmbeck
Hamburg, 22291, Germany
Asklepios
Harburg, 21075, Germany
Lungenklinik
Hemer, 58675, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Klinikverbund Kempten-Oberallgäu
Kempten, 87439, Germany
Marienhof Koblenz
Koblenz, 56073, Germany
HELIOS Klinikum Krefeld
Krefeld, 47805, Germany
Lungenklinik Lostau
Lostau, 39291, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Universitätsklinikum Magdeburg
Magdeburg, 39120, Germany
Katholisches Klinikum Mainz
Mainz, 55131, Germany
Krankenhaus Martha-Maria
München, 81479, Germany
Städt. Klinikum München-Harlaching
München, 81545, Germany
Städt. Klinikum München-Bogenhausen
München, 81925, Germany
Ruppiner Kliniken GmbH
Neuruppin, 16816, Germany
Brüderkrankenhaus St. Josef Paderborn
Paderborn, 33098, Germany
Universitätsklinikum
Regensburg, 93053, Germany
RoMed Klinikum Rosenheim
Rosenheim, 83022, Germany
Helios Kliniken Schwerin
Schwerin, 19049, Germany
Krankenhaus Bethanien Solingen
Solingen, 42699, Germany
Krankenhaus vom Roten Kreuz
Stuttgart, 70372, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Saarland Heilstätten GmbH
Völklingen, 66333, Germany
Petrus-Krankenhaus
Wuppertal, 42282, Germany
Medizinisches Zentrum Städte Region Aachen GmbH
Würselen, 52146, Germany
Centro Médico Teknon
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
Hospital Universitario Quirón
Madrid, 28223, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Quiron
Málaga, Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46026, Spain
Inselspital
Bern, CH-3010, Switzerland
Hôpitaux Universitaires de Genève (HUG)
Geneva, 1211, Switzerland
CHUV
Lausanne, 1011, Switzerland
L'hôpital Neuchâtelois - Pourtalès
Neuchâtel, 2000, Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, 9007, Switzerland
Lungenzentrum Hirslanden
Zurich, 8032, Switzerland
UniversitätsSpital Zürich
Zurich, 8091, Switzerland
Heartlands Birmingham
Birmingham, B9 4 LS, United Kingdom
Bristol Royal Infirmary
Bristol, BS2 8HW, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Guy's and St Thomas' Hospital
London, SE1 9RT, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Hetzel, Prof.
Krankenhaus vom Roten Kreuz
- PRINCIPAL INVESTIGATOR
Christian Schumann, MD
Klinikenverbund Kempten-Oberallgäu
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2013
First Posted
March 7, 2013
Study Start
May 1, 2013
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
July 16, 2021
Record last verified: 2021-07