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

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Device: IPS System

• Registration Number: NCT01716598
• Lead Sponsor: Nuvaira, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-30
• Primary Completion: 2014-05
• Study Completion: 2016-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	IPS System	Targeted Lung Denervation Therapy (TLD Therapy)

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	365 Days	Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.

Secondary Outcome Measures

Name	Time	Method
Performance	365 days	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.

Trial Locations

Locations (4)

Centre Hospitalier et Universitaire de Grenoble; 🇫🇷 Grenoble, France

Centre Hospitalier University de Reims; 🇫🇷 Reims, France

Nouvel Hopital Civil; 🇫🇷 Strasbourg, France

Otto-Wagner Hospital and Medical Center; 🇦🇹 Sanatoriumstrasse 2, Vienna, Austria