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Evaluation of the Safety and Efficacy of TLD in Patients with COPD

NCT03639051 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2024-11-14

No results posted yet for this study

Summary

The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD.

Conditions

Interventions

DEVICE

Targeted Lung Denervation (TLD)

Targeted Lung Denervation (TLD) Therapy is a bronchoscopically guided, minimally invasive procedure using the Nuvaira™ Lung Denervation System.

OTHER

Optimal Medical Care

Taking regular maintenance medication that minimally includes a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA).

Sponsors & Collaborators

  • Nuvaira, Inc.

    lead INDUSTRY

Principal Investigators

  • Frank Sciurba, MD · University of Pittsburgh Medical Center

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2024-10-01
Completion
2028-09-30
FDA Device
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03639051 on ClinicalTrials.gov