Venous InsufficiencyNCT01346553
Safety and Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI)
A study testing ESVV device in people with Venous Insufficiency, run by GB-Veintech at 1 site in Israel.
Trial summary
The External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way venous valve and a sensor that identifies the movement of the calf muscles pump. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- ESVV device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Jan 2012
- Phase
- Interventional
- 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
- Males and females age 18 and up.
- Patient is diagnosed to have deep chronic venous insufficiency (CVI) proved by recent duplex examination.
- Patient able to comprehend and give informed consent for participation in this study.
- Patient must commit to both screening and treatment visits.
- Patient must sign the Informed Consent Form.
Who cannot join
- Acute deep vein thrombosis.
- Chronic deep vein obstruction.
- Peripheral arterial occlusive disease.
- Ankle edema that is not caused by chronic venous insufficiency
- Partial or complete immobility.
- Pregnancy.
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- Known cognitive disorder.
- Drug abuse.
- Patient objects to the study protocol.
- Concurrent participation in any other clinical study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofe Medical Center
Zrifin
Hanna Levy, Dr., +972-4-638-8837, hanna@qsitemed.com
About this study
Official title: Safety and Primary Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI) Sequel - A Pilot Study
The External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way venous valve and a sensor that identifies the movement of the calf muscles pump. The external device is located above the failed deep vein and exerts synchronized intermittent regulated pressure on it. Alteration in the vein structure is occurred and the blood flows in the cephalad direction, preventing the return toward the feet. The device is synchronized with the calf muscles pump to function as a one-way venous valve. This study was design in order to assess safety and efficacy of using the ESVV for treatment of consequences of deep chronic venous insufficiency.
- Conditions
- Venous Insufficiency
- Being tested
- ESVV device
- Keywords
- Chronic Venous Insufficiency (CVI)
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESVV deviceDevice
Also called Chronic Venous Insufficiency (CVI)treatment
wearing the ESVV device for 6 hours
| Study group | Role | What they receive |
|---|---|---|
| ESVV treatment | Experimental | using ESVV device Receives: Device: ESVV device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of using the ESVV for CVI treatment
Adverse events will be documented
Measured: 6 hours
Secondary outcomes (1)
Assessing the efficacy of using the ESVV for treatment of consequences of CVI.
The efficacy of using the ESVV for the treatment of deep CVI will be established by an increase of at least 100% in PPG recovery time (RT)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GB-Veintech
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Arie Bass, Prof., Principal investigator, Assaf Harofe Medical Center, Zrifin, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346553
- Sponsor's protocol ID
- ESVV - PS-01
- Status last verified
- Apr 2011
- First submitted
- 30 Apr 2011
- Last updated
- 3 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Primary Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI) Sequel - A Pilot Study
- ClinicalTrials.gov ID
- NCT01346553
- Acronym / sponsor ID
- ESVV - PS-01
- Conditions
- Venous Insufficiency
- Keywords
- Chronic Venous Insufficiency (CVI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- GB-VeintechIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 3 May 2011 (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 External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way venous valve and a sensor that identifies the movement of the calf muscles pump. The external device is located above the failed deep vein and exerts synchronized intermittent regulated pressure on it. Alteration in the vein structure is occurred and the blood flows in the cephalad direction, preventing the return toward the feet. The device is synchronized with the calf muscles pump to function as a one-way venous valve. This study was design in order to assess safety and efficacy of using the ESVV for treatment of consequences of deep chronic venous insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESVV treatment | Experimental | Device: ESVV deviceusing ESVV device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females age 18 and up.
- Patient is diagnosed to have deep chronic venous insufficiency (CVI) proved by recent duplex examination.
- Patient able to comprehend and give informed consent for participation in this study.
- Patient must commit to both screening and treatment visits.
- Patient must sign the Informed Consent Form.
Key exclusion criteria (10 listed)
- Acute deep vein thrombosis.
- Chronic deep vein obstruction.
- Peripheral arterial occlusive disease.
- Ankle edema that is not caused by chronic venous insufficiency
- Partial or complete immobility.
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 |
|---|---|---|
| ESVV deviceAlso: Chronic Venous Insufficiency (CVI)treatmentwearing the ESVV device for 6 hours | Device | ESVV treatment |
Primary outcome
The safety of using the ESVV for CVI treatment
Time frame: 6 hours
Adverse events will be documented
1 secondary outcome
Assessing the efficacy of using the ESVV for treatment of consequences of CVI.
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
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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.
Arie Bass, Prof. principal investigator
Assaf Harofe Medical Center, Zrifin, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESVV device in people with Venous Insufficiency, run by GB-Veintech at 1 site in Israel.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 May 2011. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Levy, Dr. (+972-4-638-8837, hanna@qsitemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of using the ESVV for CVI treatment (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2011.