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Surgery or Noninvasive Therapy for Varicose Veins

NCT00529672 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2010-11-16

No results posted yet for this study

Summary

For more than 100 years, surgery has been the standard of care of varicose veins of the legs. The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively high recurrence rate in the long term (up to 40%). In the last decade, several new techniques have become available but they have not yet been compared to surgery. This trail will evaluate the effectiveness, patients' perspective and cost effectiveness of surgery and non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous laser therapy.

Conditions

  • Varicose Vein

Interventions

PROCEDURE

crossectomy and short stripping

under spinal or complete anaesthesia

PROCEDURE

ultrasound guided sclerotherapy with foam

1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein\>

PROCEDURE

endovenous laser therapy

940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.

Sponsors & Collaborators

Principal Investigators

  • Martino Neumann, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00529672 on ClinicalTrials.gov