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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00992680
First received: October 7, 2009
Last updated: April 17, 2014
Last verified: April 2014

October 7, 2009
April 17, 2014
September 2009
October 2010   (final data collection date for primary outcome measure)
Improvement in exercise capacity. [ Time Frame: 3mo, 6mo, and 12mo ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00992680 on ClinicalTrials.gov Archive Site
Incidence of complications and adverse events. [ Time Frame: 3mo, 6mo, and 12mo ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
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)
  • Experimental: Group A
    Anastomotic Coupler System + standard of care per GOLD
    Intervention: Device: ROX Anastomotic Coupler System (ACS)
  • No Intervention: Group B
    Standard of care per GOLD alone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
December 2013
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00992680
US-01
Yes
ROX Medical, Inc.
ROX Medical, Inc.
Not Provided
Not Provided
ROX Medical, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP