Sponsor study identifier
observational
460
1 country
3
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 11, 2014
Actual (reported)December 1, 2014
Actual (reported)October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
long-term QoL follow-up of patients after UGFS and surgical stripping
6-10 years follow-up
Clinical recurrence
6-10 years follow-up
Technical recurrence
6-10 years follow-up
Number of retreatments
6-10 years follow-up
Venous Clinical Severity Score change
6-10 years follow-up
6-10 years post classical stripping of the great saphenous vein.
6-10 years post post ultrasound guided foam sclerotherapy of the great saphenous vein.
Patients who were randomized and received the allocated treatment UGFS or surgical stripping.
Department of Dermatology, Atrium Medical Centre.
Heerlen, Limburg, Netherlands
Maastricht UMC+
Maastricht, Limburg, 6202AZ, Netherlands
Departments of Dermatology and Surgery, Laurentius Hospital
Roermond, Limburg, Netherlands
Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, van Neer P, vd Kley J, de Haan E, Sommer A. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;99(8):1062-70. doi: 10.1002/bjs.8781. Epub 2012 May 25.
Lam YL, Lawson JA, Toonder IM, Shadid NH, Sommer A, Veenstra M, van der Kleij AMJ, Ceulen RP, de Haan E, Ibrahim F, van Dooren T, Nieman FH, Wittens CHA. Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein. Br J Surg. 2018 May;105(6):692-698. doi: 10.1002/bjs.10762.
C.H.A. Wittens, M.D. PhD
Maastricht UMC
First Submitted
November 11, 2014
First Posted
December 1, 2014
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Estimated (date passed)COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 2, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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