Post Market Observational, Prospective, Multi-center Study

Emphysema Clinical Trial

Official title:

Post Market Observational, Prospective, Multi-center Registry Using the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01806636
• Other study ID #: CLN0014
• Status: Terminated
• Start date: May 2013
• Est. completion date: July 2019

Study information

• Verified date: July 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1275
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emphysema

Intervention

Device:
• PneumRx Coil System

Locations

Country	Name	City	State
Austria	Otto-Wagner-Spital	Wien
Denmark	Rigshospitalet Copenhaven	Copenhagen
Germany	Hochtaunus-Kliniken, Klinik für Pneumolog und Onkologie	Bad Homburg
Germany	Charité Campus Mitte	Berlin
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Gemeinschaftskrankenhaus Havelhöhe	Berlin
Germany	Helios Klinikum Emil von Behring, Berlin	Berlin-Zehlendorf
Germany	Universitätsklinikum Bonn	Bonn
Germany	Ev. Krankenhaus Göttingen-Weende	Bovenden
Germany	DRK Klinik am Bürgerpark	Bremerhaven
Germany	Kreiskliniken Altötting-Burghausen	Burghausen
Germany	Schwarzwald-Baar-Klinikum	Donaueschingen
Germany	Klinik Donaustauf	Donaustauf
Germany	Medizinische Klinik Nord	Dortmund
Germany	HELIOS Klinikum Duisburg	Duisburg
Germany	Johanniter KH Duisburg Rheinhausen	Duisburg
Germany	Pneumologische Klinik Waldhof Elgershausen	Elgershausen
Germany	Ruhrlandklinik	Essen
Germany	Bethanien Krankenhaus	Frankfurt am Main
Germany	St. Elisabethen Krankenhaus	Frankfurt am Main
Germany	Klinikum Fürth	Fürth
Germany	Asklepios-Klinikum Gauting	Gauting
Germany	SRH Wald-Klinikum Gera GmbH	Gera
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Diakoniekrankenhaus Halle	Halle
Germany	Universitätsklinikum Halle	Halle
Germany	Asklepios Klinik Barmbeck	Hamburg
Germany	Uniklinik Eppendorf	Hamburg
Germany	Asklepios	Harburg
Germany	Lungenklinik	Hemer
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Klinikverbund Kempten-Oberallgäu	Kempten
Germany	Marienhof Koblenz	Koblenz
Germany	St. Marien-Hospital	Köln
Germany	HELIOS Klinikum Krefeld	Krefeld
Germany	Lungenklinik Lostau	Lostau
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Katholisches Klinikum Mainz	Mainz
Germany	Krankenhaus Martha-Maria	München
Germany	Städt. Klinikum München-Bogenhausen	München
Germany	Städt. Klinikum München-Harlaching	München
Germany	Ruppiner Kliniken GmbH	Neuruppin
Germany	Brüderkrankenhaus St. Josef Paderborn	Paderborn
Germany	Universitätsklinikum	Regensburg
Germany	RoMed Klinikum Rosenheim	Rosenheim
Germany	Helios Kliniken Schwerin	Schwerin
Germany	Krankenhaus Bethanien Solingen	Solingen
Germany	Krankenhaus vom Roten Kreuz	Stuttgart
Germany	Universitätsklinikum Ulm	Ulm
Germany	Saarland Heilstätten GmbH	Völklingen
Germany	Petrus-Krankenhaus	Wuppertal
Germany	Medizinisches Zentrum Städte Region Aachen GmbH	Würselen
Spain	Centro Médico Teknon	Barcelona
Spain	Hospital de Basurto	Bilbao
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Quirón	Madrid
Spain	Hospital Quiron	Malaga
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Switzerland	Inselspital	Bern
Switzerland	Hôpitaux Universitaires de Genève (HUG)	Geneve
Switzerland	CHUV	Lausanne
Switzerland	L'hôpital Neuchâtelois - Pourtalès	Neuchâtel
Switzerland	Kantonsspital Sankt Gallen	St. Gallen
Switzerland	Lungenzentrum Hirslanden	Zürich
Switzerland	UniversitätsSpital Zürich	Zürich
United Kingdom	Heartlands Birmingham	Birmingham
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Guy's and St Thomas' Hospital	London
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Southampton General Hospital	Southampton

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	PneumRx, Inc.

Countries where clinical trial is conducted

Austria,  Denmark,  Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Quality of Life (QOL) measures		6 months and yearly up to three years post treatment 1
Secondary	Changes in Pulmonary Function and Exercise Capacity test results		6 months and yearly up to three years post treatment 1
Secondary	Safety including any device malfunction or failure(s)		6 months and yearly up to three years post treatment 1