Back to resultsEvaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema
Primary Purpose
Emphysema
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema focused on measuring LVRS (Lung Volume Reduction Surgery), LVRC (Lung Volume Reduction Coil), Emphysema, coil, RePneu
Eligibility Criteria
Inclusion Criteria:
Subject > 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form
Exclusion Criteria:
Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Sites / Locations
- University Medical Center Groningen - UMCG
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LVRC Treatment
Arm Description
Outcomes
Primary Outcome Measures
6 minute walk test (6MWT)
The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up.
Secondary Outcome Measures
Adverse Events
The safety objective of this study is to identify the adverse effects attributed to device.
Full Information
NCT ID
NCT01421082
First Posted
August 18, 2011
Last Updated
July 15, 2021
Sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01421082
Brief Title
Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema
Official Title
Evaluation of Physiologic Parameters to Study the Mechanism of Action of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in Subjects With Homogeneous Emphysema
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
LVRS (Lung Volume Reduction Surgery), LVRC (Lung Volume Reduction Coil), Emphysema, coil, RePneu
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LVRC Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)
Other Intervention Name(s)
Lung Volume Reduction Surgery (LVRS), Lobectomy
Intervention Description
Lung Volume Reduction Coil (LVRC)
Primary Outcome Measure Information:
Title
6 minute walk test (6MWT)
Description
The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
The safety objective of this study is to identify the adverse effects attributed to device.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject > 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form
Exclusion Criteria:
Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Facility Information:
Facility Name
University Medical Center Groningen - UMCG
City
Groningen
State/Province
The Netherlands
ZIP/Postal Code
9700 RB
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema
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