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Trial record 3 of 3 for:    Holaira

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
Sponsor:
Information provided by (Responsible Party):
Nuvaira, Inc.

Tracking Information
First Submitted Date  ICMJE November 29, 2011
First Posted Date  ICMJE December 1, 2011
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE October 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
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. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Targeted Lung Denervation
Targeted Lung Denervation
Intervention: Device: TLD Therapy (IPS SystemTM)
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2012)
22
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2011)
8
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01483534
Other Study ID Numbers  ICMJE CLP-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nuvaira, Inc.
Study Sponsor  ICMJE Nuvaira, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Center Groningen
PRS Account Nuvaira, Inc.
Verification Date February 2016

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