search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ROX Anastomotic Coupler System (ACS)
Sponsored by
ROX Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Pulmonary Emphysema, Walk

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pulmonary Associates
  • UCLA Medical Center
  • Orlando Regional Health Care System
  • Sarasota Memorial Hospital
  • Veritas Clinical Specialties, LTD
  • Franklin Square Hospital
  • Caritas St. Elizabeth's Medical Center
  • Beth Israel Deaconess Medical Center
  • Oklahoma State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Arm Description

Anastomotic Coupler System + standard of care per GOLD

Standard of care per GOLD alone

Outcomes

Primary Outcome Measures

Improvement in exercise capacity.

Secondary Outcome Measures

Incidence of complications and adverse events.

Full Information

First Posted
October 7, 2009
Last Updated
April 17, 2014
Sponsor
ROX Medical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00992680
Brief Title
A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Official Title
A Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ROX Medical, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Pulmonary Emphysema, Walk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Anastomotic Coupler System + standard of care per GOLD
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Standard of care per GOLD alone
Intervention Type
Device
Intervention Name(s)
ROX Anastomotic Coupler System (ACS)
Intervention Description
The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)
Primary Outcome Measure Information:
Title
Improvement in exercise capacity.
Time Frame
3mo, 6mo, and 12mo
Secondary Outcome Measure Information:
Title
Incidence of complications and adverse events.
Time Frame
3mo, 6mo, and 12mo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pulmonary Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1690
Country
United States
Facility Name
Orlando Regional Health Care System
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Veritas Clinical Specialties, LTD
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Franklin Square Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135-2997
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Oklahoma State University Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19353352
Citation
Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783.
Results Reference
background
PubMed Identifier
24484754
Citation
Faul J, Schoors D, Brouwers S, Scott B, Jerrentrup A, Galvin J, Luitjens S, Dolan E. Creation of an iliac arteriovenous shunt lowers blood pressure in chronic obstructive pulmonary disease patients with hypertension. J Vasc Surg. 2014 Apr;59(4):1078-83. doi: 10.1016/j.jvs.2013.10.069. Epub 2014 Jan 28.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs