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

IPS-II Study: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) - A Pilot Study.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: IPS System

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna
    • Sanatoriumstrasse 2, Vienna, Austria, 1140
      • Otto-Wagner Hospital and Medical Center
• France
  • Grenoble, France
    • Centre Hospitalier et Universitaire de Grenoble
  • Reims, France
    • Centre Hospitalier University de Reims
  • Strasbourg, France
    • Nouvel Hôpital Civil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; Targeted Lung Denervation Therapy (TLD Therapy)	Device: IPS System; TLD Therapy will be achieved bronchoscopically.; Other Names: TLD Therapy; Targeted Lung Denervation Therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	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.	365 days

Collaborators and Investigators

• Sponsor: Nuvaira, Inc.
• Investigators: Principal Investigator: Arschang Valipour, MD, FCCP, Ass. Prof., Otto-Wagner Hospital, Vienna, Austria

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: October 4, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (ESTIMATE): October 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: COPD; TLD Therapy; Targeted Lung Denervation Therapy; IPS; Innovative Pulmonary Solutions, Inc.; Holaira, Inc.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CLP-002; CVI-12-03-005102 (OTHER: Eudamed Number)