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Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (IPS-I)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483534
First Posted: December 1, 2011
Last Update Posted: September 23, 2016
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.
Information provided by (Responsible Party):
Nuvaira, Inc.
November 29, 2011
December 1, 2011
September 23, 2016
October 2011
November 2013   (Final data collection date for primary outcome measure)
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.
Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure. [ Time Frame: To 180-days post procedure. ]
Complete list of historical versions of study NCT01483534 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation
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
The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
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
Experimental: Targeted Lung Denervation
Targeted Lung Denervation
Intervention: Device: TLD Therapy (IPS SystemTM)
Slebos DJ, Klooster K, Koegelenberg CF, Theron J, Styen D, Valipour A, Mayse M, Bolliger CT. Targeted lung denervation for moderate to severe COPD: a pilot study. Thorax. 2015 May;70(5):411-9. doi: 10.1136/thoraxjnl-2014-206146. Epub 2015 Mar 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2015
November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • FEV1 30% to 60%
  • FEV1/FVC <70%
  • Prior smoker (at least 10 pack years)
  • Quit smoking for at least 6 months

Exclusion Criteria:

  • Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
  • Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
  • Pulmonary nodule requiring surgery
  • Presence of implantable electronic devices
  • Active respiratory infection within recent weeks
  • COPD exacerbation within recent weeks
  • Recent Myocardial infarction (MI)
  • Recent and unstable or life threatening arrhythmia
  • Malignancy treated with radiation or chemotherapy within the last 2 years
  • Presence or clinical diagnosis of other respiratory diseases other than COPD
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   South Africa
 
 
NCT01483534
CLP-001
Yes
Not Provided
Not Provided
Nuvaira, Inc.
Nuvaira, Inc.
Not Provided
Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Center Groningen
Nuvaira, Inc.
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP