Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: TLD Therapy (IPS SystemTM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted Lung Denervation<br>Targeted Lung Denervation | Device: TLD Therapy (IPS SystemTM)<br>* 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.<br>* Other names: TLD Therapy, Targeted Lung Denervation Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure. | 365 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Feasibility | The ability to access the target treatment area and deliver RF energy to the target treatment site. | At time of Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Pulmonary, Intervention, Device, Denervation, Lung, Holaira, Inc., Innovative Pulmonary Solutions, Inc.