Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System

NCT ID: NCT03840187

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-11

Study Completion Date

2020-01-15

Brief Summary

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Correlation between colposcopist findings and digital cervicography employing Gynescope system

Detailed Description

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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.

Conditions

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Cervical Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Digital cervicography

Colposcopist findings and digital cervicography employing Gynescope system

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- Patients reffered for colposcopy

Exclusion Criteria

Patient refusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Barzilai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ofer Gemer, Professor

Role: PRINCIPAL_INVESTIGATOR

Barzilai University Medical Center Ashkelon

Locations

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Barzilay University Medical Center

Ashkelon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0097-18-BRZ

Identifier Type: -

Identifier Source: org_study_id

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