Lung Volume Reduction Via Coils in Patients With COPD

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Chronic Obstructive Pulmonary Disease (COPD)
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Clinical Trial Details

NCT number	NCT02246569
Study type	Observational
Source	RWTH Aachen University
Contact	Michael Dreher, Univ.-Prof.
Phone	+49241 80 88763
Email	mdreher@ukaachen.de
Status	Recruiting
Phase	N/A
Start date	October 2015
Completion date	September 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.