Post Market Observational, Prospective, Multi-center Study

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.

Study Overview

• Status: Terminated
• Conditions: Emphysema
• Intervention / Treatment: Device: PneumRx Coil System

• Study Type: Observational
• Enrollment (Actual): 1275

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1140
    • Otto-Wagner-Spital
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet Copenhaven
• Germany
  • Bad Homburg, Germany, 61352
    • Hochtaunus-Kliniken, Klinik für Pneumolog und Onkologie
  • Berlin, Germany, 10117
    • Charité Campus Mitte
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum
  • Berlin, Germany, 14089
    • Gemeinschaftskrankenhaus Havelhöhe
  • Berlin-Zehlendorf, Germany, 14165
    • Helios Klinikum Emil von Behring, Berlin
  • Bonn, Germany, 53105
    • Universitätsklinikum Bonn
  • Bovenden, Germany, 37120
    • Ev. Krankenhaus Göttingen-Weende
  • Bremerhaven, Germany, 27574
    • DRK Klinik am Bürgerpark
  • Burghausen, Germany, 84489
    • Kreiskliniken Altötting-Burghausen
  • Donaueschingen, Germany, 78166
    • Schwarzwald-Baar-Klinikum
  • Donaustauf, Germany, 93093
    • Klinik Donaustauf
  • Dortmund, Germany, 44145
    • Medizinische Klinik Nord
  • Duisburg, Germany, 47166
    • Helios Klinikum Duisburg
  • Duisburg, Germany, 47228
    • Johanniter KH Duisburg Rheinhausen
  • Elgershausen, Germany, 35753
    • Pneumologische Klinik Waldhof Elgershausen
  • Essen, Germany, 45239
    • Ruhrlandklinik
  • Frankfurt am Main, Germany, 60487
    • St. Elisabethen Krankenhaus
  • Frankfurt am Main, Germany, 60487
    • Bethanien Krankenhaus
  • Fürth, Germany, 90766
    • Klinikum Fürth
  • Gauting, Germany, 82131
    • Asklepios-Klinikum Gauting
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera GmbH
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald
  • Halle, Germany, 06120
    • Universitätsklinikum Halle
  • Halle, Germany, 6114
    • Diakoniekrankenhaus Halle
  • Hamburg, Germany, 20246
    • Uniklinik Eppendorf
  • Hamburg, Germany, 22291
    • Asklepios Klinik Barmbeck
  • Harburg, Germany, 21075
    • ASklepios
  • Hemer, Germany, 58675
    • Lungenklinik
  • Immenhausen, Germany, 34376
    • Lungenfachklinik Immenhausen
  • Kempten, Germany, 87439
    • Klinikverbund Kempten-Oberallgäu
  • Koblenz, Germany, 56073
    • Marienhof Koblenz
  • Krefeld, Germany, 47805
    • Helios Klinikum Krefeld
  • Köln, Germany, 50668
    • St. Marien-Hospital
  • Lostau, Germany, 39291
    • Lungenklinik Lostau
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein
  • Magdeburg, Germany, 39120
    • Universitätsklinikum Magdeburg
  • Mainz, Germany, 55131
    • Katholisches Klinikum Mainz
  • München, Germany, 81479
    • Krankenhaus Martha-Maria
  • München, Germany, 81545
    • Städt. Klinikum München-Harlaching
  • München, Germany, 81925
    • Städt. Klinikum München-Bogenhausen
  • Neuruppin, Germany, 16816
    • Ruppiner Kliniken GmbH
  • Paderborn, Germany, 33098
    • Brüderkrankenhaus St. Josef Paderborn
  • Regensburg, Germany, 93053
    • Universitätsklinikum
  • Rosenheim, Germany, 83022
    • RoMed Klinikum Rosenheim
  • Schwerin, Germany, 19049
    • HELIOS Kliniken Schwerin
  • Solingen, Germany, 42699
    • Krankenhaus Bethanien Solingen
  • Stuttgart, Germany, 70372
    • Krankenhaus vom Roten Kreuz
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm
  • Völklingen, Germany, 66333
    • Saarland Heilstätten GmbH
  • Wuppertal, Germany, 42282
    • Petrus-Krankenhaus
  • Würselen, Germany, 52146
    • Medizinisches Zentrum Städte Region Aachen GmbH
• Spain
  • Barcelona, Spain
    • Centro Medico Teknon
  • Bilbao, Spain
    • Hospital de Basurto
  • Madrid, Spain
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 28223
    • Hospital Universitario Quirón
  • Malaga, Spain
    • Hospital Quirón
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La Fe
• Switzerland
  • Bern, Switzerland, CH-3010
    • Inselspital
  • Geneve, Switzerland, 1211
    • Hôpitaux universitaires de Genève (HUG)
  • Lausanne, Switzerland, 1011
    • CHUV
  • Neuchâtel, Switzerland, 2000
    • L'hôpital Neuchâtelois - Pourtalès
  • St. Gallen, Switzerland, 9007
    • Kantonsspital Sankt Gallen
  • Zürich, Switzerland, 8091
    • Universitatsspital Zurich
  • Zürich, Switzerland, 8032
    • LungenZentrum Hirslanden
• United Kingdom
  • Birmingham, United Kingdom, B9 4 LS
    • Heartlands Birmingham
  • Bristol, United Kingdom, BS2 8HW
    • Bristol Royal Infirmary
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' Hospital
  • Preston, United Kingdom, PR2 9HT
    • Royal Preston Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; Patients treated with PneumRx Coil System	Device: PneumRx Coil System; Other Names: LVRC; RePneu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Quality of Life (QOL) measures	6 months and yearly up to three years post treatment 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: PneumRx, Inc.
• Investigators: Principal Investigator: Martin Hetzel, Prof., Krankenhaus vom Roten Kreuz; Principal Investigator: Christian Schumann, MD, Klinikenverbund Kempten-Oberallgäu

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: February 17, 2013
• First Submitted That Met QC Criteria: March 5, 2013
• First Posted (Estimate): March 7, 2013

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: RePneu; Coil; LVRC; PneumRx
• Additional Relevant MeSH Terms: Pathologic Processes; Emphysema
• Other Study ID Numbers: CLN0014