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Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

NCT01483534 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-09-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DEVICE

TLD Therapy (IPS SystemTM)

Targeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment.

Sponsors & Collaborators

  • Nuvaira, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-11-30
Completion
2015-11-30

Countries

  • Netherlands
  • South Africa

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 NCT01483534 on ClinicalTrials.gov