CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 328 enrolled
Drug / intervention
"Three Rings Vulvoscopy" (TRIV) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02732145
NCT02732145N/ACompleted
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Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis

Ginekološka Poliklinika Dr. Vesna Harni·interventional·Posted Apr 8, 2016·Updated Oct 30, 2019

In Brief

A clinical study evaluating "Three Rings Vulvoscopy" (TRIV) and Histopathology for Lichen Sclerosus and 3 related conditions. Completed, enrolled 328 participants across 1 site.

Detailed Summary

The objective of the study was to determine sensitivity, specificity and diagnostic accuracy of "Three Rings Vulvoscopy" for detection of vulvar dermatosis using histopathology as the reference standard.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLichen Sclerosus, Lichen Planus, Lichen Simplex Chronicus, Vulvodynia
CountriesCroatia
CollaboratorsKlinički Bolnički Centar Zagreb, University of Zagreb

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2016
Enrollment StartDec 1, 2011
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 10.2 years ago

Interventions

"Three Rings Vulvoscopy" (TRIV)other

Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during "Three Rings Vulvoscopy" technique (TRIV Form Data). Assessing of the data by the "Vulvoscopy Index" and the "N-S-P Scheme".

Histopathologyprocedure

Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.