Evaluation of the IPS System for TLD Therapy in Patients With COPD (IPS-II)
|ClinicalTrials.gov Identifier: NCT01716598|
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : September 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Device: IPS System||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2012|
|Primary Completion Date :||May 2014|
|Study Completion Date :||April 2016|
Targeted Lung Denervation Therapy (TLD Therapy)
Device: IPS System
TLD Therapy will be achieved bronchoscopically.
- Primary Safety Endpoint [ Time Frame: 365 Days ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|