Primary Varicose VeinsNCT04537052
A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT)
A study testing Ven Restoration Therapy in people with Primary Varicose Veins, run by Kahramanmaras Sutcu Imam University.
Trial summary
To present the 9. months clinical results of percutaneous Ven Restoration Therapy (VRT), a new method in the treatment of primary femoral vein insufficiency.Twenty four patients diagnosed with isolated primary femoral vein insufficiency between January 2020 and December 2020 were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Varicose Veins
- What is being tested?
- Ven Restoration Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2020to 30 Jan 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with isolated deep venous insufficiency, without accompanying superficial venous insufficiency,
- volunteering to take part in the study were included
Who cannot join
- post-thrombotic or congenital deep venous insufficiency
- Venous reflux disease in the GSV diagnosed by clinical symptoms
- Local or systemic infection
About this study
Official title: A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT) Erdinç EROĞLU
To present the 9. months clinical results of percutaneous Ven Restoration Therapy (VRT), a new method in the treatment of primary femoral vein insufficiency.Twenty four patients diagnosed with isolated primary femoral vein insufficiency between January 2020 and December 2020 were included in the study. Before the procedure, junctional femoral vein diameters and reflux times were measured. CEAP classification and Venous clinical severity scores (VCSS) were recorded. Chronic Venous Insufficiency Questionnaire (CIVIQ-20) were also recorded. Then, VRT was applied percutaneously to the anterior and posterior of the femoral veins of the patients, and the diameter of the femoral vein was narrowed and valve coaptation was achieved. After the procedure, vein diameters and reflux times were measured again. All parameters were reevaluated by calling patients for control at 1.,3., 6. and 9. months.
- Conditions
- Primary Varicose Veins
- Being tested
- Ven Restoration Therapy
- Keywords
- Deep venous insufficiency,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ven Restoration TherapyProcedure or surgery
This is a novel and promising method, applied percutaneously, in the treatment of deep venous insufficiency . In this method, developed based on the effects of compression garments, a polymer consisting of cyanoacrylate and hyaluronic acid is injected, with ultrasound-guidance, percutaneously around the femoral vein. In this way, the diameter of the vein is reduced, and function is restored to the inadequately functioning valve. The procedure is also called percutaneous valvuloplasty. The underlying idea in the development of this product was that hyaluronic acid might cause an increase in connective tissue, while cyanoacrylate could serve as an exoskeleton by forming heavy tissue.
| Study group | Role | What they receive |
|---|---|---|
| Onl Femoral vein | Experimental | Ultrasound-guided controlled injection begins, and the venous diameter and gap between valves are reduced Receives: Procedure: Ven Restoration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
femoral vein diameters
reduce femoral vein diameter
Measured: 9 months
reflux times
reduce reflux times
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start27 Sep 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Varicose VeinsStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdinç Eroğlu, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537052
- Sponsor's protocol ID
- 11-2020/01
- Status last verified
- Sep 2020
- First submitted
- 1 Jun 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT) Erdinç EROĞLU
- ClinicalTrials.gov ID
- NCT04537052
- Acronym / sponsor ID
- 11-2020/01
- Conditions
- Primary Varicose Veins
- Keywords
- Deep venous insufficiency,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 27 Sep 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 3 Sep 2020 (actual)
- 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 present the 9. months clinical results of percutaneous Ven Restoration Therapy (VRT), a new method in the treatment of primary femoral vein insufficiency.Twenty four patients diagnosed with isolated primary femoral vein insufficiency between January 2020 and December 2020 were included in the study. Before the procedure, junctional femoral vein diameters and reflux times were measured. CEAP classification and Venous clinical severity scores (VCSS) were recorded. Chronic Venous Insufficiency Questionnaire (CIVIQ-20) were also recorded. Then, VRT was applied percutaneously to the anterior and posterior of the femoral veins of the patients, and the diameter of the femoral vein was narrowed and valve coaptation was achieved. After the procedure, vein diameters and reflux times were measured again. All parameters were reevaluated by calling patients for control at 1.,3., 6. and 9. months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Onl Femoral vein | Experimental | Procedure: Ven Restoration TherapyUltrasound-guided controlled injection begins, and the venous diameter and gap between valves are reduced |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with isolated deep venous insufficiency, without accompanying superficial venous insufficiency,
- volunteering to take part in the study were included
Key exclusion criteria (3 listed)
- post-thrombotic or congenital deep venous insufficiency
- Venous reflux disease in the GSV diagnosed by clinical symptoms
- Local or systemic infection
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 |
|---|---|---|
| Ven Restoration TherapyThis is a novel and promising method, applied percutaneously, in the treatment of deep venous insufficiency . In this method, developed based on the effects of compression garments, a polymer consisting of cyanoacrylate and hyaluronic acid is injected, with ultrasound-guidance, percutaneously around the femoral vein. In this way, the diameter of the vein is reduced, and function is restored to the inadequately functioning valve. The procedure is also called percutaneous valvuloplasty. The underlying idea in the development of this product was that hyaluronic acid might cause an increase in connective tissue, while cyanoacrylate could serve as an exoskeleton by forming heavy tissue. | Procedure or surgery | Onl Femoral vein |
Primary outcome
femoral vein diameters
Time frame: 9 months
reduce femoral vein diameter
reflux times
Time frame: 9 months
reduce reflux times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ven Restoration Therapy in people with Primary Varicose Veins, run by Kahramanmaras Sutcu Imam University.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
femoral vein diameters (time frame: 9 months). The study lists 2 primary outcomes in all. 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 Sep 2020.