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

NCT ID: NCT01716598

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-04-30

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Targeted Lung Denervation Therapy (TLD Therapy)

Group Type: EXPERIMENTAL

IPS System

Intervention Type: DEVICE

TLD Therapy will be achieved bronchoscopically.

Interventions

IPS System

TLD Therapy will be achieved bronchoscopically.

Intervention Type: DEVICE

Other Intervention Names

TLD Therapy; Targeted Lung Denervation Therapy

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuvaira, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arschang Valipour, MD, FCCP, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Otto-Wagner Hospital, Vienna, Austria

Locations

Otto-Wagner Hospital and Medical Center

Sanatoriumstrasse 2, Vienna, Austria

Centre Hospitalier et Universitaire de Grenoble

Grenoble, , France

Centre Hospitalier University de Reims

Reims, , France

Nouvel Hopital Civil

Strasbourg, , France

Countries

Austria; France

Other Identifiers

CVI-12-03-005102

Identifier Type: OTHER

Identifier Source: secondary_id

CLP-002

Identifier Type: -

Identifier Source: org_study_id