Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients

ROX Medical, Inc.46 enrolled

Overview

To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.

Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease that leads to irreversible changes in the lung structure, but also to systemic changes in the body that can influence the severity of the disease. The irreversible changes to the lungs can be seen in limitations in the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX AC1 on exercise capacity and respiratory quality of life.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Arteriovenous Fistula (ROX AC1)DEVICE

The percutaneous creation of an arteriovenous fistula.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination. Exclusion Criteria: * Subject not qualifying because of physical or psychological condition that may put them at risk of participating.

Locations (1)

Universitätsklinikum Gieβen und Marburg, Standort Marburg

Marburg, Germany

Outcomes

Primary Outcomes

Improvement in exercise capacity.

Time frame: 12 weeks post-procedure

Secondary Outcomes

Improvement in quality of life.

Time frame: 12 weeks post-procedure

Data from ClinicalTrials.gov

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