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

Completed

• Conditions: 10038716; chronic bronchitis; COPD

• Registration Number: NL-OMON39206
• Lead Sponsor: Holaira, Inc. (IPS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 11

Inclusion Criteria

FEV1 30% - 60% of predicted
FEV1/FVC <70%
Positive change in FEV1 of greater than 15% following administration of ipratropium
Non-smoking for a minimum of 6 months and a minimum of 10 packyears of smoking

Exclusion Criteria

Asthma
Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
Presence of a pacemaker, internal defibrillator or other implantable electronic devices

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Safety Endpoint: Freedom from documented and sustained worsening of<br /><br>COPD directly attributable to the investigational device or procedure to<br /><br>180-days post TLD Therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Technical Feasibility (performance) Endpoint: The ability of the IPS System to<br /><br>access the target treatment area and deliver RF energy to the target treatment<br /><br>site as confirmed by the IPS Console.</p><br>