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

NCT00992680 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2014-04-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • ROX Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-10-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00992680 on ClinicalTrials.gov