Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (IPS-I)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01483534|
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Device: TLD Therapy (IPS SystemTM)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2015|
Experimental: Targeted Lung Denervation
Targeted Lung Denervation
Device: TLD Therapy (IPS SystemTM)
Targeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment.
Other Name: TLD Therapy, Targeted Lung Denervation Therapy
- Primary Safety Endpoint [ Time Frame: 365 days post procedure ]Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
- Technical Feasibility [ Time Frame: At time of Treatment ]The ability to access the target treatment area and deliver RF energy to the target treatment site.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483534
|University Medical Center Groningen (UMCG)|
|Groningen, Netherlands, 9700|
|Panorama, Cape Town, South Africa|
|Capetown, South Africa, 7505|
|Principal Investigator:||Dirk-Jan Slebos, MD, PhD||University Medical Center Groningen|