Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01483534
NCT01483534
Completed
Phase 1

Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study

Nuvaira, Inc.3 sites in 2 countries22 target enrollmentOctober 2011
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsChronic Obstructive Pulmonary Disease (COPD)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Nuvaira, Inc.
Enrollment
22
Locations
3
Primary Endpoint
Primary Safety Endpoint
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
November 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •FEV1 30% to 60%
  • •FEV1/FVC \<70%
  • •Prior smoker (at least 10 pack years)
  • •Quit smoking for at least 6 months

Exclusion Criteria

  • •Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
  • •Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
  • •Pulmonary nodule requiring surgery
  • •Presence of implantable electronic devices
  • •Active respiratory infection within recent weeks
  • •COPD exacerbation within recent weeks
  • •Recent Myocardial infarction (MI)
  • •Recent and unstable or life threatening arrhythmia
  • •Malignancy treated with radiation or chemotherapy within the last 2 years
  • •Presence or clinical diagnosis of other respiratory diseases other than COPD

Outcomes

Primary Outcomes

Primary Safety Endpoint

Time Frame: 365 days post procedure

Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.

Secondary Outcomes

  • Technical Feasibility(At time of Treatment)

Study Sites (3)

Loading locations...

Similar Trials

Completed
Not Applicable
Targeted Lung Denervation for Patients With Moderate to Severe COPDChronic Obstructive Pulmonary Disease (COPD)
NCT02058459Nuvaira, Inc.128
Completed
Phase 1
Evaluation of the IPS System for TLD Therapy in Patients With COPDChronic Obstructive Pulmonary Disease (COPD)
NCT01716598Nuvaira, Inc.15
Recruiting
Not Applicable
Evaluation of Safety and Effectiveness of TLD Radiofrequency Ablation in the Treatment of COPDCOPD
NCT05799664Hangzhou Broncus Medical Co., Ltd.200
Completed
Not Applicable
Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure（PADN-CpcPH-PILOT）Pulmonary HypertensionHeart Failure
NCT05996562Pulnovo Medical (Wuxi) Co., Ltd.30
Completed
Not Applicable
Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Studychronic bronchitisCOPD10038716
NL-OMON39206Holaira, Inc. (IPS)11