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

January 27, 2015 updated by: ROX Medical, Inc.

A Study of the Effect of the ROX Percutaneous Arteriovenous Fistula System (ROX AC1) on Exercise Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Marburg, Germany, D-35043
        • Universitätsklinikum Gieβen und Marburg, Standort Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Group A Anastomotic Coupler
Device: ROX Anastomotic Coupler System (ACS). The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
Device: Arteriovenous Fistula (ROX AC1)
The percutaneous creation of an arteriovenous fistula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in exercise capacity.
Time Frame: 12 weeks post-procedure
12 weeks post-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in quality of life.
Time Frame: 12 weeks post-procedure
12 weeks post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ROX Medical, Inc.

Investigators

  • Principal Investigator: Claus Vogelmeier, MD, Universitätsklinikum Gieβen und Marburg, Standort Marburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROX IX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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