Lung Volume Reduction Via Coils in Patients With COPD

NCT ID: NCT02246569

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-09-30

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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%)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Dreher, Univ.-Prof.

Role: PRINCIPAL_INVESTIGATOR

RWTH University Hospital MK1

Locations

RWTH Univerity Hospital MK1

Aachen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Michael Dreher, Univ.-Prof.

Role: CONTACT

mdreher@ukaachen.de

+49241 80 88763

Tobias Müller, PD Dr.med.

Role: CONTACT

tobmueller@ukaachen.de

+49241 80 88763

Facility Contacts

Michael Dreher, Univ.-Prof.

Role: primary

mdreher@ukaachen.de

+492418088763

Tobias Müller, PD Dr.med.

Role: backup

tobmueller@ukaachen.de

+492418088763

Other Identifiers

14-001

Identifier Type: -

Identifier Source: org_study_id