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Lung Volume Reduction Via Coils in Patients With COPD

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ClinicalTrials.gov Identifier: NCT02246569
Recruitment Status : Unknown
Verified November 2015 by RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : September 22, 2014
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:

For patients with emphysema lung volume reduction (ELVR) could be an expedient approach for the reduction of distension of the lung. ELVR may be performed using RePneu® Coils. After the insertion of the coils distended lung sections shrink so that healthy parts can expand.

In the present study investigators intend to examine, whether the insertion of the coils improves diaphragm function and force of the breathing muscles. Investigators hypothesize that reduction of lung volume eliminates or reduces flattening of the diaphragm and relieves breathing muscles, respectively respiratory pump, which aims to reduce dyspnea.


Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)

Detailed Description:

In line with routine explorations it is necessary to clarify whether a patient is suitable for the endoscopic lung volume reduction. To address this question lung function diagnostics, 6-minutes-walk-test, blood withdrawal, CT of the thorax, lung perfusion scintigraphy and transthoracic echocardiography have to be performed.

After confirmation of the suitability for the endoscopic lung volume reduction patients who fulfill all other eligibility criteria will be educated about the aim and performance of the study by an investigator. After reading the patient information patient may submit his informed written consent. After that information on the risks will be given by a treating physician.

Following examination will be performed additional due to the study: determination of the strength of breathing muscles, determination of the life quality index via St.-George-questionary and determination of the depression score via SF-8-questionary (short form-8).

After that coils will be implanted and a permanent post-operative examination will be performed for 24 hours.

Three, respectively nine month after the implanting follow up exploration will be performed on the study patients.


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Study Type : Observational
Estimated Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Impact of Endoscopic Lung Volume Reduction Via Coils on Inspiratory Muscle Strength in Patients With COPD
Study Start Date : October 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016



Primary Outcome Measures :
  1. breathing strength [ Time Frame: Change of breathing strength 3 (respectively 9) months after the bronchoscopy ]
    Maximal Inspiratory Pressure (PImax) Maximal Expiratory Pressure (PEmax) Neuromuscular drive (P0.1) Sniff nasal pressure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with severe COPD (GOLD stage III or IV)
Criteria

Inclusion Criteria:

  • bilateral lung emphysema after CT with sufficient amount of tissue to perform RePneu Coil implantation at the discretion of the treating physicians
  • homogeneous or heterogeneous emphysema
  • previous guidelines-based therapy of COPD (including vaccinations against Pneumococcal infections and seasonal influenza)
  • nicotine abstention for not less than three months, documented by CO-HB (haemoglobin) < 2%
  • FEV 1 (Forced Expiratory Volume 1 / one second capacity) ≤ 45% of reference value, after bronchodilatation
  • total lung capacity (TLC) ≥ 100% of reference value
  • residual volume (RV) ≥ 175% of reference value
  • patient's suitability for endoscopic lung volume reduction according to multidisciplinary decision of pneumology and thorax surgery division.
  • signed Informed Consent
  • understanding of the nature, significance and implications of the study
  • ability to understand and follow instructions of the study stuff

Exclusion Criteria:

  • echo-cardiographic right ventricular pressure (PAPsys) > 50 mmHg
  • indication for a permanent anticoagulation therapy (besides ASS)
  • pulmonal cachexia
  • pregnancy and lactating
  • permanent treatment with > 20 mg Prednison per day
  • hospitalisation due to a COPD-exacerbation in the last 3 months
  • > 3 steroid-treated exacerbations in the last year
  • Increase of FEV1 (Forced Expiratory Volume) ≥ 20% after bronchodilatation
  • severe diffusion impairment (DLCO < 20%)

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): NCT02246569


Contacts
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Contact: Michael Dreher, Univ.-Prof. +49241 80 88763 mdreher@ukaachen.de
Contact: Tobias Müller, PD Dr.med. +49241 80 88763 tobmueller@ukaachen.de

Locations
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Germany
RWTH Univerity Hospital MK1 Recruiting
Aachen, Germany, 52074
Contact: Michael Dreher, Univ.-Prof.    +492418088763    mdreher@ukaachen.de   
Contact: Tobias Müller, PD Dr.med.    +492418088763    tobmueller@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Michael Dreher, Univ.-Prof. RWTH University Hospital MK1

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02246569     History of Changes
Other Study ID Numbers: 14-001
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by RWTH Aachen University:
Chronic obstructive pulmonary disease (COPD)
endoscopic lung volume reduction
RePneu®Coils
physical capacity
quality of life
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases