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History of Changes for Study: NCT01716598
Evaluation of the IPS System for TLD Therapy in Patients With COPD (IPS-II)
Latest version (submitted September 22, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 25, 2012 None (earliest Version on record)
2 May 21, 2013 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures, Study Design, Conditions and Study Identification
3 July 30, 2014 Study Status
4 September 8, 2015 Study Status
5 September 22, 2016 Recruitment Status and Study Status
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Study NCT01716598
Submitted Date:  October 25, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: CLP-002
Brief Title: Evaluation of the IPS System for TLD Therapy in Patients With COPD (IPS-II)
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.
Secondary IDs: CVI-12-03-005102 [Eudamed Number]
Open or close this module Study Status
Record Verification: October 2012
Overall Status: Recruiting
Study Start: October 2012
Primary Completion: October 2013 [Anticipated]
Study Completion: October 2014 [Anticipated]
First Submitted: October 4, 2012
First Submitted that
Met QC Criteria:
October 25, 2012
First Posted: October 30, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 25, 2012
Last Update Posted: October 30, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Nuvaira, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
TLD Therapy
Targeted Lung Denervation Therapy
IPS
Innovative Pulmonary Solutions, Inc.
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 35 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
2. 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.
Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age:
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Central Contact Person: Scott Grant
Telephone: 1.425.440.0486
Email: scott.grant@innovativepulmonary.com
Study Officials: Christopher T Bolliger, MD, Ph.D., FCCP
Principal Investigator
University of Stellenbosch
Dirk-Jan Slebos, MD, PhD
Principal Investigator
University Medical Center Groningen
Locations: Austria, Vienna
Otto-Wagner Hospital and Medical Center
[Recruiting]
Sanatoriumstrasse 2, Vienna, Austria, 1140
Contact:Contact: Arschang Valipour, Assoc. Prof. Med arschang.valipour@wienkav.at
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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