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Targeted Lung Denervation for Patients With Moderate to Severe COPD

NCT02058459 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-04-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DEVICE

Holaira™ Lung Denervation System with energy delivery

DEVICE

Holaira™ Lung Denervation System without energy delivery

Sponsors & Collaborators

  • Nuvaira, Inc.

    lead INDUSTRY

Principal Investigators

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

  • Arschang Valipour, MD · Otto-Wagner-Spital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-04
Primary Completion
2018-01-26
Completion
2020-06-16

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Netherlands
  • United Kingdom

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 NCT02058459 on ClinicalTrials.gov