HypertensionPhase 2NCT01682057

A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension

A Phase 2 study testing ROX ANASTOMOTIC COUPLER SYSTEM (ACS) in people with Hypertension, run by ROX Medical, Inc. at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Hypertension
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: 8 participants
Where: 1 siteBelgium
Study dates: Oct 2011to Mar 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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination

Who cannot join

Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Universitair Ziekenhuis Brussel
Brussels, 1090

Other trials in Belgium

About this study

Official title: A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension

The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.

Conditions: Hypertension
Being tested: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)
Keywords: High Blood Pressure, Hypertension, Resistant Hypertension
Medical subject headings: Hypertension

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 ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
ROX Anastomotic Coupler System (ACS)Device

Study groups in NCT01682057
Study group	Role	What they receive
Group A	Experimental	ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications Receives: Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in mean office SBP
Change in mean office SBP at six months as compared to Baseline
Measured: Baseline, 6 months

Secondary outcomes (1)

Change in mean office DBP
Change in mean office DBP at six months as compared to Baseline
Measured: Change in mean office DBP six months as compared to Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Mar 2013

First posted10 Sep 2012 (estimated)
Study startOct 2011
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01682057
Sponsor's protocol ID: RH-01
Status last verified: Jan 2015
First submitted: 5 Sep 2012
Last updated: 29 Jan 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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 Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension
ClinicalTrials.gov ID: NCT01682057
Acronym / sponsor ID: RH-01
Conditions: Hypertension
Keywords: High Blood Pressure, Hypertension, Resistant Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: ROX Medical, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 10 Sep 2012 (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 performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Group A	Experimental	Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination

Key exclusion criteria (1 listed)

Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.

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 ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).	Device	Group A
ROX Anastomotic Coupler System (ACS)	Device	Group A

Primary outcome

Change in mean office SBP
Time frame: Baseline, 6 months
Change in mean office SBP at six months as compared to Baseline

1 secondary outcome

Change in mean office DBP
Time frame: Change in mean office DBP six months as compared to Baseline

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.

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Not yet recruitingObservational study
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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.

1 site 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 Hypertension, run by ROX Medical, Inc. at 1 site in Belgium.

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 Belgium. 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?

Change in mean office SBP (time frame: Baseline, 6 months). 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 NCT01682057.

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.