Evaluation of the IPS System for TLD Therapy in Patients With COPD

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: IPS System


Participation Criteria
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Eligibility Criteria
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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)

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: Treatment<br>Targeted Lung Denervation Therapy (TLD Therapy) | Device: IPS System<br>* TLD Therapy will be achieved bronchoscopically.<br>* Other names: 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | Performance will be evaluated as the ability of the IPS System to access the target treatment area and deliver RF energy to the target treatment site at the time of the procedure, as well as confirmation of clinical evidence of successful lung denervation. | 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, TLD Therapy, Targeted Lung Denervation Therapy, IPS, Innovative Pulmonary Solutions, Inc., Holaira, Inc.