Post Market Observational, Prospective, Multi-center Study

NCT ID: NCT01806636

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

1275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emphysema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Patients treated with PneumRx Coil System

PneumRx Coil System

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PneumRx Coil System

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RePneu LVRC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PneumRx, Inc.

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Hetzel, Prof.

Role: PRINCIPAL_INVESTIGATOR

Krankenhaus vom Roten Kreuz

Christian Schumann, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikenverbund Kempten-Oberallgäu

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Otto-Wagner-Spital

Vienna, , Austria

Site Status

Rigshospitalet Copenhaven

Copenhagen, , Denmark

Site Status

Hochtaunus-Kliniken, Klinik für Pneumolog und Onkologie

Bad Homburg, , Germany

Site Status

Charité Campus Mitte

Berlin, , Germany

Site Status

Charité Campus Virchow-Klinikum

Berlin, , Germany

Site Status

Gemeinschaftskrankenhaus Havelhöhe

Berlin, , Germany

Site Status

Helios Klinikum Emil von Behring, Berlin

Berlin-Zehlendorf, , Germany

Site Status

Universitätsklinikum Bonn

Bonn, , Germany

Site Status

Ev. Krankenhaus Göttingen-Weende

Bovenden, , Germany

Site Status

DRK Klinik am Bürgerpark

Bremerhaven, , Germany

Site Status

Kreiskliniken Altötting-Burghausen

Burghausen, , Germany

Site Status

St. Marien-Hospital

Cologne, , Germany

Site Status

Schwarzwald-Baar-Klinikum

Donaueschingen, , Germany

Site Status

Klinik Donaustauf

Donaustauf, , Germany

Site Status

Medizinische Klinik Nord

Dortmund, , Germany

Site Status

HELIOS Klinikum Duisburg

Duisburg, , Germany

Site Status

Johanniter KH Duisburg Rheinhausen

Duisburg, , Germany

Site Status

Pneumologische Klinik Waldhof Elgershausen

Elgershausen, , Germany

Site Status

Ruhrlandklinik

Essen, , Germany

Site Status

Bethanien Krankenhaus

Frankfurt am Main, , Germany

Site Status

St. Elisabethen Krankenhaus

Frankfurt am Main, , Germany

Site Status

Klinikum Fürth

Fürth, , Germany

Site Status

Asklepios-Klinikum Gauting

Gauting, , Germany

Site Status

SRH Wald-Klinikum Gera GmbH

Gera, , Germany

Site Status

Universitätsmedizin Greifswald

Greifswald, , Germany

Site Status

Universitätsklinikum Halle

Halle, , Germany

Site Status

Diakoniekrankenhaus Halle

Halle, , Germany

Site Status

Uniklinik Eppendorf

Hamburg, , Germany

Site Status

Asklepios Klinik Barmbeck

Hamburg, , Germany

Site Status

Asklepios

Harburg, , Germany

Site Status

Lungenklinik

Hemer, , Germany

Site Status

Lungenfachklinik Immenhausen

Immenhausen, , Germany

Site Status

Klinikverbund Kempten-Oberallgäu

Kempten, , Germany

Site Status

Marienhof Koblenz

Koblenz, , Germany

Site Status

HELIOS Klinikum Krefeld

Krefeld, , Germany

Site Status

Lungenklinik Lostau

Lostau, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status

Universitätsklinikum Magdeburg

Magdeburg, , Germany

Site Status

Katholisches Klinikum Mainz

Mainz, , Germany

Site Status

Krankenhaus Martha-Maria

München, , Germany

Site Status

Städt. Klinikum München-Harlaching

München, , Germany

Site Status

Städt. Klinikum München-Bogenhausen

München, , Germany

Site Status

Ruppiner Kliniken GmbH

Neuruppin, , Germany

Site Status

Brüderkrankenhaus St. Josef Paderborn

Paderborn, , Germany

Site Status

Universitätsklinikum

Regensburg, , Germany

Site Status

RoMed Klinikum Rosenheim

Rosenheim, , Germany

Site Status

Helios Kliniken Schwerin

Schwerin, , Germany

Site Status

Krankenhaus Bethanien Solingen

Solingen, , Germany

Site Status

Krankenhaus vom Roten Kreuz

Stuttgart, , Germany

Site Status

Universitätsklinikum Ulm

Ulm, , Germany

Site Status

Saarland Heilstätten GmbH

Völklingen, , Germany

Site Status

Petrus-Krankenhaus

Wuppertal, , Germany

Site Status

Medizinisches Zentrum Städte Region Aachen GmbH

Würselen, , Germany

Site Status

Centro Médico Teknon

Barcelona, , Spain

Site Status

Hospital de Basurto

Bilbao, , Spain

Site Status

Hospital Universitario Quirón

Madrid, , Spain

Site Status

Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Quiron

Málaga, , Spain

Site Status

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Site Status

Inselspital

Bern, , Switzerland

Site Status

Hôpitaux Universitaires de Genève (HUG)

Geneva, , Switzerland

Site Status

CHUV

Lausanne, , Switzerland

Site Status

L'hôpital Neuchâtelois - Pourtalès

Neuchâtel, , Switzerland

Site Status

Kantonsspital Sankt Gallen

Sankt Gallen, , Switzerland

Site Status

Lungenzentrum Hirslanden

Zurich, , Switzerland

Site Status

UniversitätsSpital Zürich

Zurich, , Switzerland

Site Status

Heartlands Birmingham

Birmingham, , United Kingdom

Site Status

Bristol Royal Infirmary

Bristol, , United Kingdom

Site Status

Leicester Royal Infirmary

Leicester, , United Kingdom

Site Status

Guy's and St Thomas' Hospital

London, , United Kingdom

Site Status

Royal Brompton Hospital

London, , United Kingdom

Site Status

Royal Preston Hospital

Preston, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Denmark Germany Spain Switzerland United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLN0014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AeriSeal System for Lung Volume Reduction
NCT01051258 COMPLETED PHASE1/PHASE2