SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

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

Completed

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Clinic

San Diego, California, 92130, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

no consent

Treatment and study plan

Mobile OCT M3 scope

Device

Primary outcomes

image non-inferiority

Time frame: 6 months

imafge non-inferiority

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Registry information

Official study title

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.

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Oct 22, 2014
Registry last updated: May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed