Back to resultsFeasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)
Primary Purpose
Emphysema
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Lung Volume Reduction Coil (LVRC) (PneumRx's)
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema focused on measuring Emphysema, COPD, RePneu
Eligibility Criteria
Inclusion Criteria:
- Greater than or equal to 35 years of age
- bilateral heterogenous 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 significant respirator 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 clinical significant bronchiectasis
- Patient has had previous LVR surgery, lung transplant or lobectomy
- Patient has been involved in other pulmonary drug studies within 30 days prior to this study
Sites / Locations
- CHU de Nice - Hospital Pasteur
- Gaetan Deslee
- CHRU de Strasbourg-NHC
- Campus Charite Mitte
- Klinikum Donaustauf
- Asklepios
- Thoraxklinik
- Lungenklinik
- Krankenhaus von Roten Kreuz
- UKT University Hospital
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lung Volume Reduction Coil (LVRC)
Arm Description
Lung Volume Reduction Coil (LVRC)
Outcomes
Primary Outcome Measures
St. George's Respiratory Questionnaire
Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT01328899
First Posted
April 1, 2011
Last Updated
July 15, 2021
Sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01328899
Brief Title
Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)
Official Title
Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 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
This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
Emphysema, COPD, RePneu
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung Volume Reduction Coil (LVRC)
Arm Type
Experimental
Arm Description
Lung Volume Reduction Coil (LVRC)
Intervention Type
Device
Intervention Name(s)
Lung Volume Reduction Coil (LVRC) (PneumRx's)
Other Intervention Name(s)
Lung Volume Reduction Device (LVRD)
Intervention Description
Lung Volume Reduction Coil
Primary Outcome Measure Information:
Title
St. George's Respiratory Questionnaire
Description
Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Greater than or equal to 35 years of age
bilateral heterogenous 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 significant respirator 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 clinical significant bronchiectasis
Patient has had previous LVR surgery, lung transplant or lobectomy
Patient has been involved in other pulmonary drug studies within 30 days prior to this study
Facility Information:
Facility Name
CHU de Nice - Hospital Pasteur
City
Nice
Country
France
Facility Name
Gaetan Deslee
City
Reims
Country
France
Facility Name
CHRU de Strasbourg-NHC
City
Strasbourg
Country
France
Facility Name
Campus Charite Mitte
City
Berlin
Country
Germany
Facility Name
Klinikum Donaustauf
City
Donaustauf
Country
Germany
Facility Name
Asklepios
City
Gauting
Country
Germany
Facility Name
Thoraxklinik
City
Heidelberg
Country
Germany
Facility Name
Lungenklinik
City
Hemer
Country
Germany
Facility Name
Krankenhaus von Roten Kreuz
City
Stuttgart
Country
Germany
Facility Name
UKT University Hospital
City
Teubingen
Country
Germany
Facility Name
University Medical Center Groningen
City
Groningen
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
24891327
Citation
Deslee G, Klooster K, Hetzel M, Stanzel F, Kessler R, Marquette CH, Witt C, Blaas S, Gesierich W, Herth FJ, Hetzel J, van Rikxoort EM, Slebos DJ. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial. Thorax. 2014 Nov;69(11):980-6. doi: 10.1136/thoraxjnl-2014-205221. Epub 2014 Jun 2.
Results Reference
derived
Learn more about this trial
Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)
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