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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

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.

Condition or disease Intervention/treatment Phase
Heterogeneous Emphysema Device: Implantation of valves (IBV) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bronchoscopic Volume Reduction With Valve Implants After Analysis of Interlobar Fissure Integrity and Measurement of Collateral Ventilation in Patients With Severe, Heterogeneous Emphysema
Study Start Date : June 2013
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902732


Locations
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Germany
LungenClinic Grosshansdorf Recruiting
Grosshansdorf, Germany, 22927
Contact: Klaus Rabe       k.f.rabe@ungenclinic.de   
Sub-Investigator: Rabe Klaus, Prof. Dr. med.         
LungenClinic Grosshansdorf Recruiting
Großhansdorf, Germany, 22927
Contact: Henrik Watz, PD Dr. med.       H.Watz@pulmoresearch.de   
Sub-Investigator: Henrik Watz, PD Dr. med.         
Thoraxklinik Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Daniela Gompelmann, MD    +49(0)62213968087    daniela.gompelmann@thoraxklinik-heidelberg.de   
Principal Investigator: Daniela Gompelmann, MD         
Thoraxklinik Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Felix JF Herth, MD    +49 6221 396 ext 1200    Felix.Herth@thoraxklinik-heidelberg.de   
Thoraxklinik Recruiting
Heidelberg, Germany, 69126
Contact: Ralf Eberhardt, MD    +49 6221 396 ext 8204    Ralf.Eberhardt@thoraxklinik-heidelberg.de   
Sub-Investigator: Ralf Eberhardt, MD         
Sponsors and Collaborators
Heidelberg University

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Responsible Party: Felix JF Herth, Prof. Dr. med. Felix JF Herth, Heidelberg University
ClinicalTrials.gov Identifier: NCT01902732     History of Changes
Other Study ID Numbers: Protocol G1.0.- 16.02.2012
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
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Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases