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NCT02272075 Clinical Trial

SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

Cervical Cancer Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02272075
Other study ID # Scripps-Mobile OCT 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date September 2015

Study information
Verified date May 2022
Source Scripps Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: abnormal cervical cancer screening by pap smear of high risk HPV test - Exclusion Criteria: no consent -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Mobile OCT M3 scope

Locations
Country Name City State
United States Scripps Clinic San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Scripps Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary image non-inferiority imafge non-inferiority 6 months
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