Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

Nuvaira, Inc.22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

TLD Therapy (IPS SystemTM)DEVICE

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (3)

University Medical Center Groningen (UMCG)

Groningen, Netherlands

Panorama Medi-Clinic

Panorama, Cape Town, South Africa

Stellenbosch University

Capetown, South Africa

Outcomes

Primary Outcomes

Primary Safety Endpoint

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

Time frame: 365 days post procedure

Secondary Outcomes

Technical Feasibility

The ability to access the target treatment area and deliver RF energy to the target treatment site.

Time frame: At time of Treatment

Data from ClinicalTrials.gov

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