NCT04424095|UnknownDMC
Venous Disease in Pediatric Population
VEDIPEDI
Investigation of Chronic Venous Disease in Pediatric Population
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VEDIPEDI
Investigation of Chronic Venous Disease in Pediatric Population
Sponsor study identifier
observational
100
1 country
1
Study Start
February 1, 2020
Actual (reported)Primary Completion
September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Chronic venous disease (CVD) is widespread in adult subjects of western countries and is responsible of important morbidity and healthcare costs. CVD has never been extensively studied in pediatric population where the early pathophysiological alterations may occur undetected. The aim of this study is to assess the prevalence of CVD searching also for the early clinical and instrumental signs of this disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2020
Actual (reported)June 6, 2020
Actual (reported)June 9, 2020
Actual (reported)September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Prevalence of Chronic Venous Disease
The Prevalence of Chronic Venous Disease in the population study will be assessed.
at 9 month
Echo duplex evaluation
The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population
at 10 month
Recruited pediatric patients will undergo an in-office vascular visit and an echo duplex scan of lower limbs, in order to detect any symptoms or signs related to chronic venous disease.
The patient will be examined to search for signs or symptoms of chronic venous disease (teleangiectasia, reticular veins, varicose veins, skin changes, pain, itching, heavy legs, ankle edema)
The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.
Pediatric subjects, of both sex, aged between 9 and 18 years old which are cooperative for visit and diagnostic testing.
University Magna Graecia of Catanzaro
Catanzaro, 88100, Italy
Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.
Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.
Griffiths L, Vasudevan V, Myers A, Morganstern BA, Palmer LS. The role of inheritance in the development of adolescent varicoceles. Transl Androl Urol. 2018 Dec;7(6):920-925. doi: 10.21037/tau.2018.09.02.
Raffaele Serra, M.D., Ph.D.
University Magna Graecia of Catanzaro
First Submitted
June 6, 2020
First Posted
June 9, 2020
Study Start
February 1, 2020
Actual (reported)Primary Completion
September 1, 2020
Estimated (date passed)Pediatric Cardiac Output Monitoring Observational Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 9, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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