Varicose VeinNCT02241707
Does Minimal Post-operative Compression Affect the Outcome for Endovenous Ablation in Treating Varicose Vein Patients?
An observational study of Varicose Vein and Venous Insufficiency, run by NYC Surgical Associates at 1 site in United States.
Trial summary
In this proposal, the investigators seek to determine whether a reduced compression after endovenous ablation procedure in treating superficial venous insufficiency affects the outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Vein, Venous Insufficiency
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2015
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: All adults, both male/female, with varicose vein who are here in our clinic to seek for endovenous ablation treatments will be invited to participate in this study.
Who may be able to join
- Aged 18 and older
- Diagnosis - symptoms (pain, burning, itching, cramping, heaviness and tiredness of leg, restless leg, swelling leg, etc.) and clinical signs (dilated veins, lipodermatosclerosis, color and texture changes of the skin, edema of leg, wound) correlates with vein diameter >5.5mm and reflex (>0.5 sec) in the upright position identified with duplex ultrasound
- Severity/ classification - CEAP(clinical, etiologic, anatomic, and pathophysiologic) 3 or higher
- Fail to a minimum of three months of nonoperative management (leg elevation, avoidance of prolonged standing, weight reduction, daily exercise for 30 min, prescription strength gradient compression garments, NSAIDs<nonsteroidal antiinflammatory drug>)
- Post endovenous ablation (VNUS or laser) of the great saphenous vein (GSV) or small saphenous vein (SSV).
Who cannot join
- Documented allergy or intolerance to compression hosiery
- Treated vein greater than 8.5 in diameters.
- Previous history of DVT(deep venous thrombosis); Known prothrombotic state.
- Arterial insufficiency as determined by ABI(ankle-brachial index)<0.5.
- Obesity (BMI >35, class II).
Trial locations and contacts
1 site in 1 country.
United States1 site
NYC Surgical Associates, 555 Passaic Ave, Suite 10
West Caldwell, New Jersey, 07006
About this study
In this proposal, the investigators seek to determine whether a reduced compression after endovenous ablation procedure in treating superficial venous insufficiency affects the outcomes. This study involves only the use of the compression stocking post endovenous ablation procedure and everything else is standard according to current guidelines.
The investigators general strategy will be to determine the role of a minimal post-operative compression and the status of patient satisfaction including (1) Success closure rate of the treated vein. (2) Less pain; (3) Easier accepted by the patients.
Read the detailed description
All adults with varicose vein who are here in the investigators clinic to seek for endovenous ablation treatments will be invited to participate in this study. The participation in this research is entirely voluntary.
- Each patient is given a code number instead of ID(identification) in the chart. Eligible patients according to their vein size are divided into following groups using a computer-generated randomization list:
- Vein diameter between 5.5 and 6.7 mm, Post-op compression 1 day;
- Vein diameter between 5.5 and 6.7 mm, Post-op compression 7 days;
- Vein diameter between 6.8 and 8.5 mm, Post-op compression 3 days;
- Vein diameter between 6.8 and 8.5 mm, Post-op compression 7 days.
- Researchers: Data collectors and ultrasound technicians are blinded to the type of intervention, using code instead of patient's ID. The operating surgeon will not be the one who collects data. Performing physicians master these endovenous procedure techniques equally, have performed a minimum of 20 procedures independently.
- Device: Graduated medical compression hosiery, 15-20mmHg. BrightLife Direct, Washington, DC. Endovenous ablation device: 1. Radiofrequency Ablation- FDA approval 1999, VNUS RFG2, San Jose, CA; 2. Endovenous Laser ablation- FDA approval Jan 2002, TVS 1470 by Total Vein System. Wavelength 1470nm, Nano Laser System device, Houston, TX. These two procedures are standard care under current guideline.
- The research takes place over 12 months in total. During that time, it will be necessary for each patient to come to the clinic 6 times, for 1 hour each. The investigators would like to meet with every patient 1 week and 1, 3, 6, 12 months after the procedure respectively for a check-up.
- Conditions
- Varicose Vein, Venous Insufficiency
- Keywords
- Varicose vein, Endovenous ablation, Compression
- Medical subject headings
- Varicose Veins, Venous Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Vein closure success rate.
Vein closure success rate determined by clinical evidence of symptom improvement and post-procedure duplex ultrasound @ 7 days, 1, 3, 6, 12 months.
Measured: up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: Since reorganization of the institute, this study is aborted. No patient was recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- NYC Surgical Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianzhong Huang, MD, Study director, NYC Surgical AssociatesDavid A Greuner, MD, Principal investigator, NYC Surgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241707
- Sponsor's protocol ID
- NYCSA-2014-01
- Status last verified
- Apr 2015
- First submitted
- 11 Sep 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Minimal Post-operative Compression Affect the Outcome for Endovenous Ablation in Treating Varicose Vein Patients?
- ClinicalTrials.gov ID
- NCT02241707
- Acronym / sponsor ID
- NYCSA-2014-01
- Conditions
- Varicose Vein, Venous Insufficiency
- Keywords
- Varicose vein, Endovenous ablation, Compression
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Since reorganization of the institute, this study is aborted. No patient was recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYC Surgical AssociatesUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 16 Sep 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.
In this proposal, the investigators seek to determine whether a reduced compression after endovenous ablation procedure in treating superficial venous insufficiency affects the outcomes. This study involves only the use of the compression stocking post endovenous ablation procedure and everything else is standard according to current guidelines.
The investigators general strategy will be to determine the role of a minimal post-operative compression and the status of patient satisfaction including (1) Success closure rate of the treated vein. (2) Less pain; (3) Easier accepted by the patients.
Detailed description
All adults with varicose vein who are here in the investigators clinic to seek for endovenous ablation treatments will be invited to participate in this study. The participation in this research is entirely voluntary.
- Each patient is given a code number instead of ID(identification) in the chart. Eligible patients according to their vein size are divided into following groups using a computer-generated randomization list:
- Vein diameter between 5.5 and 6.7 mm, Post-op compression 1 day;
- Vein diameter between 5.5 and 6.7 mm, Post-op compression 7 days;
- Vein diameter between 6.8 and 8.5 mm, Post-op compression 3 days;
- Vein diameter between 6.8 and 8.5 mm, Post-op compression 7 days.
- Researchers: Data collectors and ultrasound technicians are blinded to the type of intervention, using code instead of patient's ID. The operating surgeon will not be the one who collects data. Performing physicians master these endovenous procedure techniques equally, have performed a minimum of 20 procedures independently.
- Device: Graduated medical compression hosiery, 15-20mmHg. BrightLife Direct, Washington, DC. Endovenous ablation device: 1. Radiofrequency Ablation- FDA approval 1999, VNUS RFG2, San Jose, CA; 2. Endovenous Laser ablation- FDA approval Jan 2002, TVS 1470 by Total Vein System. Wavelength 1470nm, Nano Laser System device, Houston, TX. These two procedures are standard care under current guideline.
- The research takes place over 12 months in total. During that time, it will be necessary for each patient to come to the clinic 6 times, for 1 hour each. The investigators would like to meet with every patient 1 week and 1, 3, 6, 12 months after the procedure respectively for a check-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults, both male/female, with varicose vein who are here in our clinic to seek for endovenous ablation treatments will be invited to participate in this study.
Key inclusion criteria (5 listed)
- Aged 18 and older
- Diagnosis - symptoms (pain, burning, itching, cramping, heaviness and tiredness of leg, restless leg, swelling leg, etc.) and clinical signs (dilated veins, lipodermatosclerosis, color and texture changes of the skin, edema of leg, wound) correlates with vein diameter >5.5mm and reflex (>0.5 sec) in the upright position identified with duplex ultrasound
- Severity/ classification - CEAP(clinical, etiologic, anatomic, and pathophysiologic) 3 or higher
- Fail to a minimum of three months of nonoperative management (leg elevation, avoidance of prolonged standing, weight reduction, daily exercise for 30 min, prescription strength gradient compression garments, NSAIDs<nonsteroidal antiinflammatory drug>)
- Post endovenous ablation (VNUS or laser) of the great saphenous vein (GSV) or small saphenous vein (SSV).
Key exclusion criteria (5 listed)
- Documented allergy or intolerance to compression hosiery
- Treated vein greater than 8.5 in diameters.
- Previous history of DVT(deep venous thrombosis); Known prothrombotic state.
- Arterial insufficiency as determined by ABI(ankle-brachial index)<0.5.
- Obesity (BMI >35, class II).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vein closure success rate.
Time frame: up to 12 months.
Vein closure success rate determined by clinical evidence of symptom improvement and post-procedure duplex ultrasound @ 7 days, 1, 3, 6, 12 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
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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.
Jianzhong Huang, MD study director
NYC Surgical Associates
David A Greuner, MD principal investigator
NYC Surgical Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Vein and Venous Insufficiency, run by NYC Surgical Associates at 1 site in United States.
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 5 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: withdrawn, as of the sponsor's last update on 29 Apr 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Vein closure success rate. (time frame: up to 12 months.). 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 29 Apr 2015.