Back to resultsInnovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (IPS-I)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TLD Therapy (IPS SystemTM)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease, Pulmonary, Intervention, Device, Denervation, Lung, Holaira, Inc., Innovative Pulmonary Solutions, Inc.
Eligibility 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
Sites / Locations
- University Medical Center Groningen (UMCG)
- Panorama Medi-Clinic
- Stellenbosch University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Targeted Lung Denervation
Arm Description
Targeted Lung Denervation
Outcomes
Primary Outcome Measures
Primary Safety Endpoint
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
The ability to access the target treatment area and deliver RF energy to the target treatment site.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01483534
Brief Title
Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation
Acronym
IPS-I
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nuvaira, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease, Pulmonary, Intervention, Device, Denervation, Lung, Holaira, Inc., Innovative Pulmonary Solutions, Inc.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted Lung Denervation
Arm Type
Experimental
Arm Description
Targeted Lung Denervation
Intervention Type
Device
Intervention Name(s)
TLD Therapy (IPS SystemTM)
Other Intervention Name(s)
TLD Therapy, Targeted Lung Denervation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.
Time Frame
365 days post procedure
Secondary Outcome Measure Information:
Title
Technical Feasibility
Description
The ability to access the target treatment area and deliver RF energy to the target treatment site.
Time Frame
At time of Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk-Jan Slebos, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen (UMCG)
City
Groningen
ZIP/Postal Code
9700
Country
Netherlands
Facility Name
Panorama Medi-Clinic
City
Panorama
State/Province
Cape Town
Country
South Africa
Facility Name
Stellenbosch University
City
Capetown
ZIP/Postal Code
7505
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
25739911
Citation
Slebos DJ, Klooster K, Koegelenberg CF, Theron J, Styen D, Valipour A, Mayse M, Bolliger CT. Targeted lung denervation for moderate to severe COPD: a pilot study. Thorax. 2015 May;70(5):411-9. doi: 10.1136/thoraxjnl-2014-206146. Epub 2015 Mar 4.
Results Reference
result
Links:
URL
http://thorax.bmj.com/content/early/2015/03/03/thoraxjnl-2014-206146
Description
Targeted lung denervation for moderate to severe COPD: a pilot study.
Learn more about this trial
Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation
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