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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992680
• Other study ID #: US-01
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2009
• Last updated: April 17, 2014
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: ROX Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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)

Locations

Country	Name	City	State
United States	Franklin Square Hospital	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	UCLA Medical Center	Los Angeles	California
United States	Orlando Regional Health Care System	Orlando	Florida
United States	Pulmonary Associates	Phoenix	Arizona
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Veritas Clinical Specialties, LTD	Topeka	Kansas
United States	Oklahoma State University Medical Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
ROX Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in exercise capacity.		3mo, 6mo, and 12mo	No
Secondary	Incidence of complications and adverse events.		3mo, 6mo, and 12mo	Yes