Varicose VeinsNCT02080013
Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
A study testing radiofrequency in people with Varicose Veins, run by Ain Shams University.
Trial summary
our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized study. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- radiofrequency
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Nov 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between the ages of 18 and 60 years with incompetent GSVs documented on duplex ultrasound (US; B-mode and color Doppler imaging) were eligible
Who cannot join
- Current deep vein thrombosis (DVT)
- Thrombus in the vein of interest
- Previous GSV treatment
- Pregnancy
- Known malignancy
- Significant arterial disease (ankle : brachial pressure index below 0•8)
- Use of anticoagulant medication.
About this study
Official title: Prospective, Randomized Study of Endovenous Segmental Radiofrequency Versus 1320 nm Laser Ablation for the Treatment of Great Saphenous Vein Reflux (RVLAb Study)
our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized study.
Read the detailed description
Endovenous Radiofrequency versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
- Conditions
- Varicose Veins
- Being tested
- radiofrequency
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequencyOther
Also called ClosureFAST
ClosureFAST
| Study group | Role | What they receive |
|---|---|---|
| ClosureFast group | Sham comparator | Radiofrequency Ablation for the Treatment of Great Saphenous Vein Reflux Receives: Other: radiofrequency |
| group 1 | Sham comparator | EVL group Endovenous Laser Ablation for the Treatment of Great Saphenous Vein Reflux Receives: Other: radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startDec 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam M. Saleh, Ain Shams University
- Investigators
- Hossam M. Saleh, PhD, Principal investigator, Vascular Surgery Department, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080013
- Sponsor's protocol ID
- JVS-D-14-00218
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2014
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study of Endovenous Segmental Radiofrequency Versus 1320 nm Laser Ablation for the Treatment of Great Saphenous Vein Reflux (RVLAb Study)
- ClinicalTrials.gov ID
- NCT02080013
- Acronym / sponsor ID
- JVS-D-14-00218
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Mar 2014 (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.
our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized study.
Detailed description
Endovenous Radiofrequency versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ClosureFast group | Sham comparator | Other: radiofrequencyRadiofrequency Ablation for the Treatment of Great Saphenous Vein Reflux |
| group 1 | Sham comparator | Other: radiofrequencyEVL group Endovenous Laser Ablation for the Treatment of Great Saphenous Vein Reflux |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18 and 60 years with incompetent GSVs documented on duplex ultrasound (US; B-mode and color Doppler imaging) were eligible
Key exclusion criteria (7 listed)
- Current deep vein thrombosis (DVT)
- Thrombus in the vein of interest
- Previous GSV treatment
- Pregnancy
- Known malignancy
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 |
|---|---|---|
| radiofrequencyAlso: ClosureFASTClosureFAST | Other | ClosureFast group, group 1 |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 30 days
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 3 Apr 2014.
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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.
Hossam M. Saleh, PhD principal investigator
Vascular Surgery Department, Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency in people with Varicose Veins, run by Ain Shams 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 1 inclusion and 7 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 3 Apr 2014. 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. Some participants in this study may receive a placebo. 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?
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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 30 days). 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 Apr 2014.