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. Identifier: NCT01483534
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):
Nuvaira, Inc.

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.

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)
Primary Purpose: Treatment
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
Primary Completion Date : November 2013
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

Arm Intervention/treatment
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 Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01483534

University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9700
South Africa
Panorama Medi-Clinic
Panorama, Cape Town, South Africa
Stellenbosch University
Capetown, South Africa, 7505
Sponsors and Collaborators
Nuvaira, Inc.
Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Center Groningen

Additional Information:
Publications of Results:
Responsible Party: Nuvaira, Inc. Identifier: NCT01483534     History of Changes
Other Study ID Numbers: CLP-001
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: February 2016

Keywords provided by Nuvaira, Inc.:
Chronic Obstructive Pulmonary Disease
Holaira, Inc.
Innovative Pulmonary Solutions, Inc.

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pharmaceutical Solutions