Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (IPS-I)

Nuvaira

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Device: TLD Therapy (IPS SystemTM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01483534

CLP-001

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Targeted Lung Denervation

Experimental group

Description:

Targeted Lung Denervation

Treatment:

Device: TLD Therapy (IPS SystemTM)