Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)

July 15, 2021 updated by: Boston Scientific Corporation

Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France
        • CHU de Nice - Hospital Pasteur
      • Reims, France
        • Gaetan Deslee
      • Strasbourg, France
        • CHRU de Strasbourg-NHC
  • Germany
      • Berlin, Germany
        • Campus Charite Mitte
      • Donaustauf, Germany
        • Klinikum Donaustauf
      • Gauting, Germany
        • ASklepios
      • Heidelberg, Germany
        • Thoraxklinik
      • Hemer, Germany
        • Lungenklinik
      • Stuttgart, Germany
        • Krankenhaus von Roten Kreuz
      • Teubingen, Germany
        • UKT University Hospital
  • Netherlands
      • Groningen, Netherlands
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Greater than or equal to 35 years of age
  • bilateral heterogenous emphysema
  • Patient has stopped smoking for a minimum of 8 weeks
  • Read, understood and signed the Informed consent form

Exclusion Criteria:

  • Patient has a history of recurrent significant respirator infection
  • Patient has an inability to walk > 140 meters
  • Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
  • Patient is pregnant or lactating
  • Patient has clinical significant bronchiectasis
  • Patient has had previous LVR surgery, lung transplant or lobectomy
  • Patient has been involved in other pulmonary drug studies within 30 days prior to this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lung Volume Reduction Coil (LVRC)
Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)
Lung Volume Reduction Coil
Other Names:
  • Lung Volume Reduction Device (LVRD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
St. George's Respiratory Questionnaire
Time Frame: 6 months
Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

PneumRx, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 4, 2011

First Posted (Estimate)

April 5, 2011

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN0011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Emphysema

Clinical Trials on Lung Volume Reduction Coil (LVRC) (PneumRx's)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe