Chronic Obstructive Pulmonary DiseasePhase 4NCT00832611
Study of the Effect of the ROX AC1 on Exercise Capacity and Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 4 study testing Arteriovenous Fistula (ROX AC1) in people with Chronic Obstructive Pulmonary Disease, run by ROX Medical, Inc. at 1 site in Germany.
Trial summary
To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Arteriovenous Fistula (ROX AC1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Nov 2011
- Phase
- Phase 4
- 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 years and older
- 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
- Subject not qualifying because of physical or psychological condition that may put them at risk of participating.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Gieβen und Marburg, Standort Marburg
Marburg, D-35043
About this study
Official title: A Study of the Effect of the ROX Percutaneous Arteriovenous Fistula System (ROX AC1) on Exercise Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.
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 in the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX AC1 on exercise capacity and respiratory quality of life.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Arteriovenous Fistula (ROX AC1)
- Keywords
- Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Chronic Emphysema
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriovenous Fistula (ROX AC1)Device
The percutaneous creation of an arteriovenous fistula.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group A Anastomotic Coupler | Experimental | 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). Receives: Device: Arteriovenous Fistula (ROX AC1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in exercise capacity.
Measured: 12 weeks post-procedure
Secondary outcomes (1)
Improvement in quality of life.
Measured: 12 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2011
- Study completionNov 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- ROX Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Vogelmeier, MD, Principal investigator, Universitätsklinikum Gieβen und Marburg, Standort Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832611
- Sponsor's protocol ID
- ROX IX
- Status last verified
- Jan 2015
- First submitted
- 28 Jan 2009
- Last updated
- 29 Jan 2015
- 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 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of the ROX Percutaneous Arteriovenous Fistula System (ROX AC1) on Exercise Capacity and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00832611
- Acronym / sponsor ID
- ROX IX
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Lung Disease, Chronic Airflow Obstruction, Chronic Bronchitis, Chronic Emphysema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- ROX Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Jan 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.
To demonstrate the efficacy of ROX AC1 (with respect to exercise capacity and quality of life) in patients with COPD.
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 in the pulmonary function. The purpose of this clinical investigation is to evaluate the performance and efficacy of the ROX AC1 on exercise capacity and respiratory quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group A Anastomotic Coupler | Experimental | Device: Arteriovenous Fistula (ROX AC1)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). |
Who may qualify
- Ages
- 18 years and older
- 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 (1 listed)
- Subject 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 |
|---|---|---|
| Arteriovenous Fistula (ROX AC1)The percutaneous creation of an arteriovenous fistula. | Device | Experimental: Group A Anastomotic Coupler |
Primary outcome
Improvement in exercise capacity.
Time frame: 12 weeks post-procedure
1 secondary outcome
Improvement in quality of life.
Time frame: 12 weeks post-procedure
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 29 Jan 2015.
- 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.
Claus Vogelmeier, MD principal investigator
Universitätsklinikum Gieβen und Marburg, Standort Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arteriovenous Fistula (ROX AC1) in people with Chronic Obstructive Pulmonary Disease, run by ROX Medical, Inc. at 1 site in Germany.
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 1 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 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: 12 weeks post-procedure). 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 NCT00832611, 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 29 Jan 2015.