A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease

April 17, 2014 updated by: ROX Medical, Inc.

A Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the safety and preliminary performance of the ROX Anastomotic Coupler System (ACS), with standard of care (as defined per GOLD) in patients with Chronic Obstructive Pulmonary Disease (COPD) as compared to standard of care alone.

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 to the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX percutaneous Anastomotic Coupler System.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates
    • California
      • Los Angeles, California, United States, 90095-1690
        • UCLA Medical Center
    • Florida
      • Orlando, Florida, United States, 32803
        • Orlando Regional Health Care System
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Veritas Clinical Specialties, Ltd
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02135-2997
        • Caritas St. Elizabeth's Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74127
        • Oklahoma State University Medical Center

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 to 80 years (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:

  • Subjects not meeting Stage III or IV Chronic Obstructive Pulmonary Disease (COPD)
  • Subjects with significant comorbidities
  • Subjects 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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Anastomotic Coupler System + standard of care per GOLD
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)
No Intervention: Group B
Standard of care per GOLD alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in exercise capacity.
Time Frame: 3mo, 6mo, and 12mo
3mo, 6mo, and 12mo

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of complications and adverse events.
Time Frame: 3mo, 6mo, and 12mo
3mo, 6mo, and 12mo

Collaborators and Investigators

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

Sponsor

ROX Medical, Inc.

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

September 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (Estimate)

October 9, 2009

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-01

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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