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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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The study plans to include patients with severe emphysema candidates to go through eLVR with coils that fulfill all inclusion criteria and none of the exclusion criteria. Patients with both homogeneous and heterogeneous emphysema will be included.

The main study intervention is the performance of a cyclo ergometry (not included in daily clinical practice) before (basal) and 6 months after going through the eLVR with coils.

The subgroup of patients with homogeneous emphysema will be randomly assigned to the following therapeutic approaches:

* Group A: treatment with 10 coils in upper lobes
* Group B: treatment with 15 coils spared in upper and lower lobes

Thus, the study includes:

* for all patients, the performance of two cycloergometries, before and 6 months after the eLVR
* Also, for the subset of homogeneous emphysema patients, an open label, randomized, parallel, two arm exploratory clinical trial.

Sample size has not been formally calculated as there are no previous available data for the primary endpoint (change inspiratory capacity). Thus, 35 patients will be included according to the expected number of patients. Recruitment period will be 24 months and patient follow up will be 6 months.

Conditions

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Pulmonary Emphysema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10 coils in upper lobes

Group Type ACTIVE_COMPARATOR

10 coils in upper lobes

Intervention Type PROCEDURE

cycloergometry

Intervention Type PROCEDURE

15 coils in upper and lower lobes

Group Type EXPERIMENTAL

15 coils in upper and lower lobes

Intervention Type PROCEDURE

cycloergometry

Intervention Type PROCEDURE

Interventions

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10 coils in upper lobes

Intervention Type PROCEDURE

15 coils in upper and lower lobes

Intervention Type PROCEDURE

cycloergometry

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Emphysematous patient
* FEV1 \< 50%
* RV \> 200%
* Diffusion \<60% \>20%
* PSP \<55 mmHg

Exclusion Criteria

* Anticoagulants/antiplatelets
* Giant bullae (\> 8 cm , 1/3 hemithorax)
* More tan three moderate/severe exacerbation per year
* Negative to sign informed consent

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No