Clinical trial NCT01806636: Post Market Observational, Prospective, Multi-center Study
Official title: Post Market Observational, Prospective, Multi-center Registry Using the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Emphysema
Keywords: Coil
RePneu
PneumRx
LVRC
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2013-03-07
Enrollment: 1275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Quality of Life (QOL) measures
timeFrame: 6 months and yearly up to three years post treatment 1
Secondary outcomes:
measure: Changes in Pulmonary Function and Exercise Capacity test results
timeFrame: 6 months and yearly up to three years post treatment 1
measure: Safety including any device malfunction or failure(s)
timeFrame: 6 months and yearly up to three years post treatment 1
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Otto-Wagner-Spital
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhaven
city: Bad Homburg
country: Germany
facility: Hochtaunus-Kliniken, Klinik für Pneumolog und Onkologie
city: Berlin-Zehlendorf
country: Germany
facility: Helios Klinikum Emil von Behring, Berlin
city: Berlin
country: Germany
facility: Charité Campus Mitte
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: Gemeinschaftskrankenhaus Havelhöhe
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Bovenden
country: Germany
facility: Ev. Krankenhaus Göttingen-Weende
city: Bremerhaven
country: Germany
facility: DRK Klinik am Bürgerpark
city: Burghausen
country: Germany
facility: Kreiskliniken Altötting-Burghausen
city: Donaueschingen
country: Germany
facility: Schwarzwald-Baar-Klinikum
city: Donaustauf
country: Germany
facility: Klinik Donaustauf
city: Dortmund
country: Germany
facility: Medizinische Klinik Nord
city: Duisburg
country: Germany
facility: HELIOS Klinikum Duisburg
city: Duisburg
country: Germany
facility: Johanniter KH Duisburg Rheinhausen
city: Elgershausen
country: Germany
facility: Pneumologische Klinik Waldhof Elgershausen
city: Essen
country: Germany
facility: Ruhrlandklinik
city: Frankfurt am Main
country: Germany
facility: Bethanien Krankenhaus
city: Frankfurt am Main
country: Germany
facility: St. Elisabethen Krankenhaus
city: Fürth
country: Germany
facility: Klinikum Fürth
city: Gauting
country: Germany
facility: Asklepios-Klinikum Gauting
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Halle
country: Germany
facility: Diakoniekrankenhaus Halle
city: Hamburg
country: Germany
facility: Uniklinik Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbeck
city: Harburg
country: Germany
facility: Asklepios
city: Hemer
country: Germany
facility: Lungenklinik
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Kempten
country: Germany
facility: Klinikverbund Kempten-Oberallgäu
city: Koblenz
country: Germany
facility: Marienhof Koblenz
city: Krefeld
country: Germany
facility: HELIOS Klinikum Krefeld
city: Köln
country: Germany
facility: St. Marien-Hospital
city: Lostau
country: Germany
facility: Lungenklinik Lostau
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mainz
country: Germany
facility: Katholisches Klinikum Mainz
city: München
country: Germany
facility: Krankenhaus Martha-Maria
city: München
country: Germany
facility: Städt. Klinikum München-Harlaching
city: München
country: Germany
facility: Städt. Klinikum München-Bogenhausen
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken GmbH
city: Paderborn
country: Germany
facility: Brüderkrankenhaus St. Josef Paderborn
city: Regensburg
country: Germany
facility: Universitätsklinikum
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin
city: Solingen
country: Germany
facility: Krankenhaus Bethanien Solingen
city: Stuttgart
country: Germany
facility: Krankenhaus vom Roten Kreuz
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Völklingen
country: Germany
facility: Saarland Heilstätten GmbH
city: Wuppertal
country: Germany
facility: Petrus-Krankenhaus
city: Würselen
country: Germany
facility: Medizinisches Zentrum Städte Region Aachen GmbH
city: Barcelona
country: Spain
facility: Centro Médico Teknon
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Madrid
country: Spain
facility: Hospital Universitario Quirón
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Malaga
country: Spain
facility: Hospital Quiron
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Bern
country: Switzerland
facility: Inselspital
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)
city: Lausanne
country: Switzerland
facility: CHUV
city: Neuchâtel
country: Switzerland
facility: L'hôpital Neuchâtelois - Pourtalès
city: St. Gallen
country: Switzerland
facility: Kantonsspital Sankt Gallen
city: Zürich
country: Switzerland
facility: Lungenzentrum Hirslanden
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Birmingham
country: United Kingdom
facility: Heartlands Birmingham
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Krankenhaus vom Roten Kreuz
name: Martin Hetzel, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikenverbund Kempten-Oberallgäu
name: Christian Schumann, MD
role: PRINCIPAL_INVESTIGATOR
References: