SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

May 10, 2022 updated by: Bruce Kahn, Scripps Health

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92130
        • Scripps Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Exclusion Criteria: no consent

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Active Comparator: active colposcope
Mobile OCT M3 scope
Device: Mobile OCT M3 scope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
image non-inferiority
Time Frame: 6 months
imafge non-inferiority
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Health

Investigators

  • Principal Investigator: Bruce Kahn, MD, Scripps Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Scripps-Mobile OCT 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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