Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System

• Sponsor: Barzilai Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03840187
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

Correlation between colposcopist findings and digital cervicography employing Gynescope system

Condition or Disease	Intervention/Treatment	Phase
Cervical Dysplasia	Diagnostic Test: Digital cervicography

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 29 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System
• Actual Study Start Date: Mar 11, 2019
• Actual Primary Completion Date: Jan 15, 2020
• Actual Study Completion Date: Jan 15, 2020

Outcome Measures

Primary Outcome Measures

1. Categorical findings according in accordance with the International Federation of Cervical Pathology Colposcopy [5 months]

   leukoplakia, aceto - white change, mosaic, punctuation, and abnormal vessels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female

Inclusion Criteria:

• Patients reffered for colposcopy

Exclusion Criteria:

Patient refusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barzilay University Medical Center	Ashkelon		Israel

Sponsors and Collaborators

• Barzilai Medical Center

Investigators

• Principal Investigator: Ofer Gemer, Professor, Barzilai University Medical Center Ashkelon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Barzilai Medical Center
• ClinicalTrials.gov Identifier: NCT03840187
• Other Study ID Numbers: 0097-18-BRZ
• First Posted: Feb 15, 2019
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Barzilai Medical Center: digital cervicography; Gynescope system
• Additional relevant MeSH terms: Uterine Cervical Dysplasia; Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Jan 18, 2020