SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Device: Mobile OCT M3 scope

• Registration Number: NCT02272075
• Lead Sponsor: Scripps Health

Brief Summary

This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.

Detailed Description

This trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded images will be evaluated be experts in colpsocopy and compared

Study Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-22
• Study Start: 2014-11
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

abnormal cervical cancer screening by pap smear of high risk HPV test -

Exclusion Criteria

no consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active colposcope	Mobile OCT M3 scope	Mobile OCT M3 scope

Primary Outcome Measures

Name	Time	Method
image non-inferiority	6 months	imafge non-inferiority

Trial Locations

Locations (1)

Scripps Clinic; 🇺🇸 San Diego, California, United States