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NCT03840187 Clinical Trial

Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System

Cervical Dysplasia Clinical Trial

Official title:
Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03840187
Other study ID # 0097-18-BRZ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 11, 2019
Est. completion date January 15, 2020

Study information
Verified date January 2019
Source Barzilai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Correlation between colposcopist findings and digital cervicography employing Gynescope system

Description:

Up to 30 women that will be referred for colposcopy examination at the standard indications will also undergo a colposcopy examination of the cervix by a gynescope. The physicain performing the optical test will record the findings in accordance with the International Federation for Cervical Pathology and Colposcopy (IFCPC) terminology. Categorical variable will be included in every record. At later stage, the images obtained by the cervicography will be evaluated and recorded in accordance with the IFCPC terminology. Correlation between the categorical findings in both assesments will be compared. The correlation measure will be performed by Kappa test according to the categorial result of both measurements.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date January 15, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients reffered for colposcopy

Exclusion Criteria:

Patient refusion

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Digital cervicography
Colposcopist findings and digital cervicography employing Gynescope system

Locations
Country Name City State
Israel Barzilay University Medical Center Ashkelon

Sponsors (1)
Lead Sponsor Collaborator
Barzilai Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Categorical findings according in accordance with the International Federation of Cervical Pathology Colposcopy leukoplakia, aceto - white change, mosaic, punctuation, and abnormal vessels 5 months
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