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Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures

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ClinicalTrials.gov Identifier: NCT01902732
Recruitment Status : Unknown
Verified July 2013 by Felix JF Herth, Heidelberg University.
Recruitment status was:  Recruiting
First Posted : July 18, 2013
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):
Felix JF Herth, Heidelberg University

Tracking Information
First Submitted Date  ICMJE June 13, 2013
First Posted Date  ICMJE July 18, 2013
Last Update Posted Date July 18, 2013
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
Improvement on pulmonary function [ Time Frame: 12 months ]
Development of lung function parameters FEV1 and RV/TLC. Increase of FEV1 of 15% and decrease of RV/TLC of 10% compared to baseline will be considered as clinically significant.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2013)
Assessment of safety and efficacy [ Time Frame: 12 months ]
Safety:
  • Evaluation of number of serious adverse events related to the treatment
  • Evaluation of migration rate of valve implants
  • Evaluation of technical difficulties during implantation of valves
Efficacy:
  • average change in lung function (FEV1, IVC, RV, TLC, RV/TLC) 30 , 90, 180 and 365 days after ELVR
  • average change in life quality (SGRQ) and in dyspnoea score (mMRC)
  • average changes in distance of six minute walk test 30, 90, 180 and 365 days after ELVR
  • average changes in physical activity at home, measured with Sensewear®-wristband for three days 30, 90, 180 and 360 days after ELVR
  • echocardiographic/laboratory chemical changes of cardiac function 30, 90, 180 and 365 days after ELVR.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures
Official Title  ICMJE Bronchoscopic Volume Reduction With Valve Implants After Analysis of Interlobar Fissure Integrity and Measurement of Collateral Ventilation in Patients With Severe, Heterogeneous Emphysema
Brief Summary This clinical trial evaluates the impact of catheter-based measurement of interloabr collateral ventilation prior to endoscopic lung volume reduction in patients with hetereogeneous emphysema and complete interlobar fissures in high resolution computed tomography.
Detailed Description 50 patients (25 per center) with heterogeneous lung emphysema with indication for endoscopic lung volume reduction by valve implantation will be prospectively included in the study. Heterogeneity of emphysema and fissure completeness of the relevant lobe will be proven from high resolution computed tomography (HRCT) prior to enrolment in the study. Fissure integrity will be analyzed by a core radiology. If fissure completeness is proved, patients will be enrolled in the study. All recruited patients will additionally receive a collateral ventilation measurement by using the Chartis® Pulmonary Assement System during a flexible bronchoscopy. Depending on the results of this measurement, patients are divided in two parallel arms: A: complete fissure integrity and low collateral ventilation (CV negative) B: complete fissure integrity and high collateral ventilation (CV positive) Following the CV measurement, each patient will receive valve therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heterogeneous Emphysema
Intervention  ICMJE Device: Implantation of valves (IBV)
Implantation of intrabronchial valves in the most emphysematous destroyed and hyperinflated lung lobe improves the elastic recoisl of the samll airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function. This positive effect is observed particularly in patients with low interlobar collateral ventilation that can be quantified by CT fissure analysis and/or catheter-based measurement.
Other Name: Spiration(R) valves
Study Arms  ICMJE Implantation of valves (IBV)
Following catheter-based measurement of collaertal ventilation, each patient is treated by a complete occlusion of the targeted lobe by intrabronchial valves.
Intervention: Device: Implantation of valves (IBV)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 15, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • written informed consent
  • ability to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements
  • severe lung emphysema (FEV1<45%, RV>150%, TLC>100%)
  • pO2>60 mmHg with 4l O2, pCO2 < 60 mmHg at rest
  • heterogeneous lung emphysema diagnosed with HRCT and perfusion scintigraphy
  • confirmed heterogeneity by YACTA®
  • disclosure of parallel channels through relevant interlobar fissures
  • age > 30 years
  • stable COPD without exacerbation 8 weeks prior to screening
  • dose of cortisone< 20 mg prednisone or equivalent OCS
  • non-smoker or ex-smoker who stopped smoking for at least 4 months prior to the screening visit
  • current CoHb < 2,5%

Exclusion Criteria:

  • BMI < 18 mg/kg2
  • significant bronchiectasis with sputum production of 4 tablespoons/day
  • 6-minute-walk distance < 150 m
  • myocardial infarction within 6 weeks prior screening visit
  • decompensated heart failure
  • cardiomyopathy with moderate or severe restricted LVF
  • long-term medication with Clopidogrel
  • status after lung resection (Lobectomy/Pneumonectomy)
  • existing pregnancy
  • female subjects of child-bearing potential without acceptable forms of contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01902732
Other Study ID Numbers  ICMJE Protocol G1.0.- 16.02.2012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Felix JF Herth, Heidelberg University
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Heidelberg University
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP