NCT03416413 Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy
| NCT ID | NCT03416413 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Imperial College London |
| Condition | Varicose Veins |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2018-02-01 |
| Primary Completion | 2025-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2018-02-01 with a primary completion date of 2025-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will be comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein. The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.
Eligibility Criteria
Inclusion Criteria: * Adults over 18 years of age * Symptomatic GSV or SSV vein reflux \> 0.5 seconds on colour Duplex * Varicose vein tributary requiring treatment Exclusion Criteria: * Current DVT * Recurrent varicose veins * Arterial disease (ABPI\<0.8) * Vein diameter \< 3mm * Preference for one of the treatment options * Patient who are unwilling to participate * Inability or unwillingness to complete questionnaires * Inability to attend follow-up appointments * Patient currently included in a study of varicose vein treatment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03416413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Varicose Veins. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03416413 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03416413 currently recruiting?
Yes, NCT03416413 is actively recruiting participants. Contact the research team at a.belramman17@imperial.ac.uk for enrollment information.
Where is the NCT03416413 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT03416413 clinical trial?
NCT03416413 is sponsored by Imperial College London. The trial plans to enroll 160 participants.