Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Device: TLD Therapy (IPS SystemTM)

• Registration Number: NCT01483534
• Lead Sponsor: Nuvaira, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-01
• Primary Completion: 2013-11
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Targeted Lung Denervation	TLD Therapy (IPS SystemTM)	Targeted Lung Denervation

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	365 days post procedure	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
Technical Feasibility	At time of Treatment	The ability to access the target treatment area and deliver RF energy to the target treatment site.

Trial Locations

Locations (3)

Panorama Medi-Clinic; 🇿🇦 Panorama, Cape Town, South Africa

University Medical Center Groningen (UMCG); 🇳🇱 Groningen, Netherlands

Stellenbosch University; 🇿🇦 Capetown, South Africa