NCT03840187

Brief Summary

Correlation between colposcopist findings and digital cervicography employing Gynescope system

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

February 4, 2019

Last Update Submit

January 15, 2020

Conditions

Cervical Dysplasia

Keywords

digital cervicographyGynescope system

Outcome Measures

Primary Outcomes (1)

  • Categorical findings according in accordance with the International Federation of Cervical Pathology Colposcopy

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

    5 months

Interventions

Digital cervicographyDIAGNOSTIC_TEST

Colposcopist findings and digital cervicography employing Gynescope system

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients reffered for colposcopy

You may qualify if:

  • \- Patients reffered for colposcopy

You may not qualify if:

  • Patient refusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barzilay University Medical Center

Ashkelon, Israel

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ofer Gemer, Professor

    Barzilai University Medical Center Ashkelon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 15, 2019

Study Start

March 11, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

January 18, 2020

Record last verified: 2019-01

Locations

IL(1)