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Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils

NCT02879331 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-03-01

No results posted yet for this study

Summary

The study hypothesis is that patients with homogeneous emphysema behave differently compared to heterogeneous emphysema with respect to exercise capacity. A better understanding of this difference will allow the investigators to choose the best treatment for each type of patient.

The main purpose of this study is to evaluate the change in exercise capacity measured by cycle ergometry in patients with severe emphysema after endoscopic lung volume reduction with coils (eLVR).

As a secondary purpose, the investigators want to perform an exploratory, randomized study to compare the results of two different therapeutic approaches in a small sample of patients with homogeneous emphysema.

Conditions

  • Pulmonary Emphysema

Interventions

PROCEDURE

10 coils in upper lobes

PROCEDURE

15 coils in upper and lower lobes

PROCEDURE

cycloergometry

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Iker Fernandez-Navamuel, MD, PhD · FJD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02879331 on ClinicalTrials.gov