Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema
Primary Purpose
Emphysema
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lung Volume Reduction Coil (LVRC)
Coils
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:
- Patient > 35 years of age
- unilateral or bilateral emphysema
- Patient has stopped smoking for a minimum of 8 weeks
- Read, understood and signed the Informed Consent form
Exclusion Criteria:
- Patient has a history of recurrent clinically significant respiratory infection
- Patient has an inability to walk >140 meters
- Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
- Patient is pregnant or lactating
- Patient has clinically significant bronchiectasis
- Patient has had previous LVR surgery, lung transplant or lobectomy
- Patient has been involved in other pulmonary drug studies with 30 days prior to this study
- Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Sites / Locations
- Klinikum Donaustauf
- Asklepios
- Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
- Lungenklinik
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
permanent Coil(s) implant, QOL measure
Arm Description
Coil implantation as treatment. Treatment is permanent implant.
Outcomes
Primary Outcome Measures
Quality of Life Assessment.
Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)
Secondary Outcome Measures
Full Information
NCT ID
NCT01220908
First Posted
September 30, 2010
Last Updated
May 9, 2023
Sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01220908
Brief Title
Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema
Official Title
Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2012 (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 objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.
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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
permanent Coil(s) implant, QOL measure
Arm Type
Experimental
Arm Description
Coil implantation as treatment. Treatment is permanent implant.
Intervention Type
Device
Intervention Name(s)
Lung Volume Reduction Coil (LVRC)
Other Intervention Name(s)
Lung Volume Reduction Surgery (LVRS), Lobectomy
Intervention Description
Implantation of Lung Volume Reduction Coil(s) (LVRC)
Intervention Type
Device
Intervention Name(s)
Coils
Other Intervention Name(s)
Lung Volume Reduction Surgery (LVRS), Lobectomy
Intervention Description
Lung Volume Reduction Coil(s)
Primary Outcome Measure Information:
Title
Quality of Life Assessment.
Description
Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)
Time Frame
Three + Months Follow-Up Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient > 35 years of age
unilateral or bilateral emphysema
Patient has stopped smoking for a minimum of 8 weeks
Read, understood and signed the Informed Consent form
Exclusion Criteria:
Patient has a history of recurrent clinically significant respiratory infection
Patient has an inability to walk >140 meters
Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
Patient is pregnant or lactating
Patient has clinically significant bronchiectasis
Patient has had previous LVR surgery, lung transplant or lobectomy
Patient has been involved in other pulmonary drug studies with 30 days prior to this study
Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
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
First Name & Middle Initial & Last Name & Degree
Prof. Felix JF Herth, MD, PhD
Organizational Affiliation
Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Donaustauf
City
Donaustauf
Country
Germany
Facility Name
Asklepios
City
Gauting
Country
Germany
Facility Name
Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Lungenklinik
City
Hemer
Country
Germany
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
3150-3610536
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
25418910
Citation
Hartman JE, Klooster K, Gortzak K, ten Hacken NH, Slebos DJ. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015 Feb;20(2):319-26. doi: 10.1111/resp.12435. Epub 2014 Nov 23.
Results Reference
derived
PubMed Identifier
22116796
Citation
Slebos DJ, Klooster K, Ernst A, Herth FJF, Kerstjens HAM. Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema. Chest. 2012 Sep;142(3):574-582. doi: 10.1378/chest.11-0730.
Results Reference
derived
Learn more about this trial
Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema
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