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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Holaira
ClinicalTrials.gov Identifier:
NCT01483534
First received: November 29, 2011
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
 Device: TLD Therapy (IPS SystemTM)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Holaira:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: 365 days post procedure ] [ Designated as safety issue: Yes ]
    Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.


Secondary Outcome Measures:
  • Technical Feasibility [ Time Frame: Acute ] [ Designated as safety issue: No ]
    The ability to access the target treatment area and deliver RF energy to the target treatment site.


Enrollment: 22
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483534

Locations
Netherlands
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
Holaira
Investigators
Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: Holaira
ClinicalTrials.gov Identifier: NCT01483534     History of Changes
Other Study ID Numbers: CLP-001
Study First Received: November 29, 2011
Last Updated: May 20, 2013
Health Authority: South Africa: National Health Research Ethics Council
Netherlands: Dutch Health Care Inspectorate

Keywords provided by Holaira:
Chronic Obstructive Pulmonary Disease
Pulmonary
Intervention
Device
 Denervation
Lung
Holaira, Inc.
Innovative Pulmonary Solutions, Inc.

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013