Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study
Primary Purpose
Pulmonary Emphysema
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
IBV Implantation
IBV Implantation
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Emphysema focused on measuring Endoscopic lung volume reduction, emphysema, COPD, Patients with bilateral heterogeneous pulmonary emphysema
Eligibility Criteria
Inclusion Criteria:
- age > 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT > 150 m
Exclusion Criteria:
- pregnant homogeneous disease FEV1 < 20%
Sites / Locations
- Thoraxklinik HeidelbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bilateral
unilateral
Arm Description
Treatment arm B - incomplete bilateral treatment of in total two lobes (contralateral). The study will only use Intrabronchial Valves™
Treatment arm A - unilateral treatment with complete closure of the worst lobe of the lungs
Outcomes
Primary Outcome Measures
Improvement in pulmonary function (FEV1) 6-minute walking test
Secondary Outcome Measures
Number of major complications(SAE)
Evaluation of the IBV migration rate
Average changes in quality of life (SGRQ)
Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)
Full Information
NCT ID
NCT00995852
First Posted
October 14, 2009
Last Updated
April 26, 2011
Sponsor
Heidelberg University
Collaborators
Olympus Corporation of the Americas
1. Study Identification
Unique Protocol Identification Number
NCT00995852
Brief Title
Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study
Official Title
Unilateral vs. Bilateral IBV Placement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
Collaborators
Olympus Corporation of the Americas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with bilateral heterogeneous pulmonary emphysema benefit to differing degrees from unilateral ELVR with complete lobe closure in comparison with incomplete bilateral treatment.
Detailed Description
Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 20 patients with bilateral heterogeneous pulmonary emphysema. All patients will undergo treatment at one study centre in Heidelberg. Patients will be considered for both unilateral and bilateral treatment with intrabronchial valves (IBV) on the basis of their emphysema distribution. Patients will be randomised to two treatment arms. 10 patients receive unilateral or bilateral treatment in each case.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Emphysema
Keywords
Endoscopic lung volume reduction, emphysema, COPD, Patients with bilateral heterogeneous pulmonary emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bilateral
Arm Type
Active Comparator
Arm Description
Treatment arm B - incomplete bilateral treatment of in total two lobes (contralateral).
The study will only use Intrabronchial Valves™
Arm Title
unilateral
Arm Type
Active Comparator
Arm Description
Treatment arm A - unilateral treatment with complete closure of the worst lobe of the lungs
Intervention Type
Device
Intervention Name(s)
IBV Implantation
Other Intervention Name(s)
Spiration IBV
Intervention Description
In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of "new" air during inspiration
Intervention Type
Device
Intervention Name(s)
IBV Implantation
Other Intervention Name(s)
Spiration IBV
Intervention Description
In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. Here one of the most advanced techniques is the implantation of intrabronchial valves. The one-way mechanism of this valve allows air to escape from the downstream lung segment without any influx of "new" air during inspiration
Primary Outcome Measure Information:
Title
Improvement in pulmonary function (FEV1) 6-minute walking test
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of major complications(SAE)
Time Frame
3 months
Title
Evaluation of the IBV migration rate
Time Frame
3 months
Title
Average changes in quality of life (SGRQ)
Time Frame
3 months
Title
Average changes in pulmonary function (FEV1, IVC, RV, TLC, RV/TLC)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 40 inhomogeneous emphysema FEV1 between 20-40% DLCO between 20-40% 6MWT > 150 m
Exclusion Criteria:
pregnant homogeneous disease FEV1 < 20%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felix JF Herth, MD
Phone
+49 6221 396
Ext
1200
Email
Felix.Herth@thoraxklinik-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Ralf Eberhardt, MD
Phone
+49 6221 396
Ext
1204
Email
Ralf.Eberhardt@rthoraxklinik-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD
Phone
+49 6221 396
Ext
1200
Email
Felix.Herth@thoraxklinik-heidelberg.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
19662969
Citation
Venuta F, Rendina EA, Coloni GF. Endobronchial treatment of emphysema with one-way valves. Thorac Surg Clin. 2009 May;19(2):255-60, x. doi: 10.1016/j.thorsurg.2009.04.002.
Results Reference
background
PubMed Identifier
19131539
Citation
Chan KM, Martinez FJ, Chang AC. Nonmedical therapy for chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2009 Jan 15;6(1):137-45. doi: 10.1513/pats.200809-114GO.
Results Reference
background
PubMed Identifier
18453355
Citation
Ingenito EP, Wood DE, Utz JP. Bronchoscopic lung volume reduction in severe emphysema. Proc Am Thorac Soc. 2008 May 1;5(4):454-60. doi: 10.1513/pats.200707-085ET.
Results Reference
background
PubMed Identifier
22459779
Citation
Eberhardt R, Gompelmann D, Schuhmann M, Reinhardt H, Ernst A, Heussel CP, Herth FJF. Complete unilateral vs partial bilateral endoscopic lung volume reduction in patients with bilateral lung emphysema. Chest. 2012 Oct;142(4):900-908. doi: 10.1378/chest.11-2886.
Results Reference
derived
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Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study
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