Completed

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

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What is being tested

ROX Anastomotic Coupler System (ACS)

Device
Who is being recruted

Bronchial Diseases+11

+ Bronchitis

+ Chronic Disease

From 18 to 80 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2009
See protocol details

Summary

Principal SponsorROX Medical, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitleA Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
NCT00992680
Principal SponsorROX Medical, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

49 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesBronchitisChronic DiseaseInfectionsLung DiseasesLung Diseases, ObstructivePathologic ProcessesPulmonary EmphysemaRespiratory Tract DiseasesRespiratory Tract InfectionsPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic ObstructiveBronchitis, Chronic

Criteria

1 inclusion criteria required to participate
Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.
3 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Anastomotic Coupler System + standard of care per GOLD

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Suspended

Pulmonary Associates

Phoenix, United StatesOpen Pulmonary Associates in Google Maps
Suspended

UCLA Medical Center

Los Angeles, United States
Suspended

Orlando Regional Health Care System

Orlando, United States
Suspended

Sarasota Memorial Hospital

Sarasota, United States
Completed9 Study Centers