IPS-II Study: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) - A Pilot Study.

Nuvaira, Inc.4 sites in 2 countries15 target enrollmentOctober 2012

ConditionsChronic Obstructive Pulmonary Disease (COPD)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Nuvaira, Inc.
Enrollment: 15
Locations: 4
Primary Endpoint: Primary Safety Endpoint
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve targeted lung denervation and potentially improve breathing and quality of life for patients suffering from COPD.

Use of the IPS System will be technically feasible in accessing the target treatment location and delivering RF energy to the target treatment location.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nuvaira, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•FEV1 30% to 60%
•Patient is diagnosed with COPD
•Positive relative change in FEV1 of greater than 15%
•Patient 40 years of age or older at the time of consent
•Smoking history of at least 10 pack years
•Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study

Exclusion Criteria

•Documented history or current evidence of pulmonary hypertension Documented history or current evidence of polycythemia level of greater
•Documented history or current evidence of congestive heart failure
•Patient has an SaO2 less than or equal to 88% or a PaO2 less than or equal to 7.3 kPa (55 mm Hg) on room air
•Patient has a PaCO2 \> 8.0 kPa (60 mm Hg)
•Prior lung transplant, LVRS, LVR, median sternotomy, bullectomy or lobectomy
•Pulmonary nodule requiring surgery
•History of recurrent respiratory infections (more than 3 hospitalizations within 1 year of enrollment)
•Presence of a pacemaker, internal defibrillator or other implantable electronic devices j. Active respiratory infection within the past 4 weeks k. COPD exacerbation within the past 4 weeks l. Myocardial infarction (MI) within the last 6 months m. Unstable or life threatening arrhythmia within the last year n. Malignancy treated with radiation or chemotherapy within the last 2 years o. Documented history of other respiratory diseases (cystic fibrosis, tuberculosis, vocal chord dysfunction, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis)