Chronic Obstructive Pulmonary DiseasePhase 2NCT00992680
A Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing ROX Anastomotic Coupler System (ACS) in people with Chronic Obstructive Pulmonary Disease, run by ROX Medical, Inc. at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- ROX Anastomotic Coupler System (ACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2009to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Franklin Square Hospital
Baltimore, Maryland, 21237
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135-2997
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
UCLA Medical Center
Los Angeles, California, 90095-1690
Orlando Regional Health Care System
Orlando, Florida, 32803
Pulmonary Associates
Phoenix, Arizona, 85006
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Veritas Clinical Specialties, LTD
Topeka, Kansas, 66606
Oklahoma State University Medical Center
Tulsa, Oklahoma, 74127
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- ROX Anastomotic Coupler System (ACS)
- Keywords
- Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Pulmonary Emphysema, Walk
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Bronchitis, Chronic, Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROX Anastomotic Coupler System (ACS)Device
The ACS will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Anastomotic Coupler System + standard of care per GOLD Receives: Device: ROX Anastomotic Coupler System (ACS) |
| Group B | No intervention | Standard of care per GOLD alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in exercise capacity.
Measured: 3mo, 6mo, and 12mo
Secondary outcomes (1)
Incidence of complications and adverse events.
Measured: 3mo, 6mo, and 12mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- ROX Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992680
- Sponsor's protocol ID
- US-01
- Status last verified
- Apr 2014
- First submitted
- 7 Oct 2009
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783.
PubMed 19353352Faul 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.
PubMed 24484754
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter, Open Label, Pilot Study to Evaluate the ROX Anastomotic Coupler System in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00992680
- Acronym / sponsor ID
- US-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Pulmonary Emphysema, Walk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- ROX Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: ROX Anastomotic Coupler System (ACS)Anastomotic Coupler System + standard of care per GOLD |
| Group B | No intervention | –Standard of care per GOLD alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of advanced Chronic Obstructive Pulmonary Disease (COPD) must be made on the basis of current findings, medical history and physical examination.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Group A |
Primary outcome
Improvement in exercise capacity.
Time frame: 3mo, 6mo, and 12mo
1 secondary outcome
Incidence of complications and adverse events.
Time frame: 3mo, 6mo, and 12mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Background: PubMed 19353352Cooper CB, Celli B. Venous admixture in COPD: pathophysiology and therapeutic approaches. COPD. 2008 Dec;5(6):376-81. doi: 10.1080/15412550802522783.
- Derived from this study: PubMed 24484754Faul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ROX Anastomotic Coupler System (ACS) in people with Chronic Obstructive Pulmonary Disease, run by ROX Medical, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in exercise capacity. (time frame: 3mo, 6mo, and 12mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00992680, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.