SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

N/ACompletedNCT02272075

Scripps Health30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cervical Cancer

Interventions

Mobile OCT M3 scopeDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: abnormal cervical cancer screening by pap smear of high risk HPV test - Exclusion Criteria: no consent \-

Locations (1)

Scripps Clinic

San Diego, California, United States

Outcomes

Primary Outcomes

image non-inferiority

imafge non-inferiority

Time frame: 6 months

Data from ClinicalTrials.gov

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