SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

Image Comparison of a Mobile Colposcope (SmartScope) vs. a Standard Colposcope for Directing Cervical Biopsies in Women With Abnormal Pap Smears: A Non-inferiority Trial.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02272075

Enrollment

Registered

2014-10-22

Start date

2014-11-30

Completion date

2015-09-30

Last updated

2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

screeening

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

Interventions

DEVICEMobile OCT M3 scope

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

no consent \-

Design outcomes

Primary

Measure	Time frame	Description
image non-inferiority	6 months	imafge non-inferiority

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026