Correlation Between Colposcopist Findings and Digital Cer... | NCT03840187

Studies
Correlation Between Colposcopist Findings and Digital Cervicography Employing Gynescope System

NCT03840187

Sponsor

Barzilai Medical Center

Status

Completed

Last Update Posted

Jan 18, 2020Actual

Enrollment

29Actual

Phase

Not provided

Conditions

Cervical Dysplasia

Interventions

Digital cervicography

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2019Actual

Primary Completion Date

Jan 15, 2020Actual

Completion Date

Jan 15, 2020Actual

First Submitted Date

Feb 4, 2019

First Submission Date that Met QC Criteria

Feb 12, 2019

First Posted Date

Feb 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2020

Last Update Posted Date

Jan 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Correlation between colposcopist findings and digital cervicography employing Gynescope system

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Digital cervicography	Diagnostic Test	Colposcopist findings and digital cervicography employing Gynescope system

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients reffered for colposcopy

Exclusion Criteria:

Patient refusion

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients reffered for colposcopy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ofer Gemer, Professor	Barzilai University Medical Center Ashkelon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barzilay University Medical Center		Ashkelon			Israel

Condition Browse Module

MeSH Terms

ID	Term
D002578	Uterine Cervical Dysplasia

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases

Browse Leaves

Not provided

Browse Branches

Not provided