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Trial record 2 of 3 for:    Holaira

Evaluation of the IPS System for TLD Therapy in Patients With COPD (IPS-II)

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: NCT01716598
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Nuvaira, Inc.

Tracking Information
First Submitted Date  ICMJE October 4, 2012
First Posted Date  ICMJE October 30, 2012
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2012)
  • Primary [ Time Frame: 180 days ]
    Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
  • Primary [ Time Frame: Acute ]
    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 as confirmed by the IPS Console at the time of the procedure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
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.
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 Evaluation of the IPS System for TLD Therapy in Patients With COPD
Official Title  ICMJE 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.
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE Device: IPS System
TLD Therapy will be achieved bronchoscopically.
Other Names:
  • TLD Therapy
  • Targeted Lung Denervation Therapy
Study Arms  ICMJE Experimental: Treatment
Targeted Lung Denervation Therapy (TLD Therapy)
Intervention: Device: IPS System
Publications * Not Provided

*   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: May 21, 2013)
15
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2012)
35
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • FEV1 30% to 60%
  • Patient is diagnosed with COPD
  • Positive relative change in FEV1 of greater than 15%
  • Patient 40 years of age or older at the time of consent
  • Smoking history of at least 10 pack years
  • Non-smoking for a minimum of 6 months prior to consent and agrees to continue not smoking for the duration of the study

Exclusion Criteria:

  • Documented history or current evidence of pulmonary hypertension Documented history or current evidence of polycythemia level of greater
  • Documented history or current evidence of congestive heart failure
  • Patient has an SaO2 less than or equal to 88% or a PaO2 less than or equal to 7.3 kPa (55 mm Hg) on room air
  • Patient has a PaCO2 > 8.0 kPa (60 mm Hg)
  • Prior lung transplant, LVRS, LVR, median sternotomy, bullectomy or lobectomy
  • Pulmonary nodule requiring surgery
  • History of recurrent respiratory infections (more than 3 hospitalizations within 1 year of enrollment)
  • Presence of a pacemaker, internal defibrillator or other implantable electronic devices j. Active respiratory infection within the past 4 weeks k. COPD exacerbation within the past 4 weeks l. Myocardial infarction (MI) within the last 6 months m. Unstable or life threatening arrhythmia within the last year n. Malignancy treated with radiation or chemotherapy within the last 2 years o. Documented history of other respiratory diseases (cystic fibrosis, tuberculosis, vocal chord dysfunction, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis)
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 Austria,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01716598
Other Study ID Numbers  ICMJE CLP-002
CVI-12-03-005102 ( Other Identifier: Eudamed Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Nuvaira, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nuvaira, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arschang Valipour, MD, FCCP, Ass. Prof. Otto-Wagner Hospital, Vienna, Austria
PRS Account Nuvaira, Inc.
Verification Date September 2016

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