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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Holaira
ClinicalTrials.gov Identifier:
NCT01716598
First received: October 4, 2012
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Device: IPS System
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Holaira:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: 365 Days ] [ 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:
  • Performance [ Time Frame: 365 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: October 2012
Estimated Study Completion Date: June 2016
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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%
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716598

Locations
Austria
Otto-Wagner Hospital and Medical Center
Sanatoriumstrasse 2, Vienna, Austria, 1140
France
Centre Hospitalier et Universitaire de Grenoble
Grenoble, France
Centre Hospitalier University de Reims
Reims, France
Nouvel Hopital Civil
Strasbourg, France
Sponsors and Collaborators
Holaira
Investigators
Principal Investigator: Arschang Valipour, MD, FCCP, Ass. Prof. Otto-Wagner Hospital, Vienna, Austria
  More Information

No publications provided

Responsible Party: Holaira
ClinicalTrials.gov Identifier: NCT01716598     History of Changes
Other Study ID Numbers: CLP-002, CVI-12-03-005102
Study First Received: October 4, 2012
Last Updated: July 30, 2014
Health Authority: Netherlands: Dutch Health Care Inspectorate
France: ANMS
Austria: BASG/AGES

Keywords provided by Holaira:
COPD
TLD Therapy
Targeted Lung Denervation Therapy
IPS
Innovative Pulmonary Solutions, Inc.
Holaira, Inc.

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

ClinicalTrials.gov processed this record on September 14, 2014