Evaluation of the IPS System for TLD Therapy in Patients With COPD (IPS-II)
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.
Chronic Obstructive Pulmonary Disease (COPD)
Device: IPS System
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Primary Safety Endpoint [ Time Frame: 365 Days ] [ Designated as safety issue: Yes ]Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
- Performance [ Time Frame: 365 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||June 2016|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Targeted Lung Denervation Therapy (TLD Therapy)
Device: IPS System
TLD Therapy will be achieved bronchoscopically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716598
|Otto-Wagner Hospital and Medical Center|
|Sanatoriumstrasse 2, Vienna, Austria, 1140|
|Centre Hospitalier et Universitaire de Grenoble|
|Centre Hospitalier University de Reims|
|Nouvel Hopital Civil|
|Principal Investigator:||Arschang Valipour, MD, FCCP, Ass. Prof.||Otto-Wagner Hospital, Vienna, Austria|