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Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

NCT01220908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-05-11

No results posted yet for this study

Summary

The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.

Conditions

  • Emphysema

Interventions

DEVICE

Lung Volume Reduction Coil (LVRC)

Implantation of Lung Volume Reduction Coil(s) (LVRC)

DEVICE

Coils

Lung Volume Reduction Coil(s)

Sponsors & Collaborators

  • PneumRx, Inc.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Dirk-Jan Slebos, MD, PhD · University Medical Center Groningen

  • Prof. Felix JF Herth, MD, PhD · Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-03-31
Completion
2012-03-31

Countries

  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01220908 on ClinicalTrials.gov