Evaluation of the IPS System for TLD Therapy in Patients With COPD (IPS-II)

Nuvaira

Status and phase

Completed

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Device: IPS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01716598

CLP-002

CVI-12-03-005102 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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)