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

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Device: IPS System Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : May 2014
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment
Targeted Lung Denervation Therapy (TLD Therapy)
Device: IPS System
TLD Therapy will be achieved bronchoscopically.
Other Names:
  • TLD Therapy
  • Targeted Lung Denervation Therapy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

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): NCT01716598

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Otto-Wagner Hospital and Medical Center
Sanatoriumstrasse 2, Vienna, Austria, 1140
Centre Hospitalier et Universitaire de Grenoble
Grenoble, France
Centre Hospitalier University de Reims
Reims, France
Nouvel Hopital Civil
Strasbourg, France
Sponsors and Collaborators
Nuvaira, Inc.
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Principal Investigator: Arschang Valipour, MD, FCCP, Ass. Prof. Otto-Wagner Hospital, Vienna, Austria
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Responsible Party: Nuvaira, Inc.
ClinicalTrials.gov Identifier: NCT01716598    
Other Study ID Numbers: CLP-002
CVI-12-03-005102 ( Other Identifier: Eudamed Number )
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Keywords provided by Nuvaira, Inc.:
TLD Therapy
Targeted Lung Denervation Therapy
Innovative Pulmonary Solutions, Inc.
Holaira, Inc.
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases