A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Device: Mobile colposcope

• Registration Number: NCT05388162
• Lead Sponsor: Scripps Health

Brief Summary

When a woman has an abnormal pap smear or tests positive for a high risk strain of the HPV virus, the current standard of care includes culposcopic examination of the cervix with biopsy. A culposcope is essentially a microscope for examining the cervix. Culposcopes cost $5-10,000 each. The device being tested in this trial is an adaptor for a smart phone that will cost \~ $125. The larger goal of this line of studies see if the images obtained using the smart phone adaptor are non-inferior to those obtained with standard culposcopes. If the device is found to provide images equal to those of standard culposscopes, it could save thousands of dollars in healthcare expenditure currently that go to the purchase and maintenance of culposcopes. This has potential world-wide applications, especially for resource poor countries. This initial trial is a non-inferiority trial to compare the images obtained with the smart phone based device of those obtained by a standard culposcope

Detailed Description

See above.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-11-27
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

adult women with abnormal pap smear or HPV virus testing referred for culposcopy -

Exclusion Criteria

none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
coposcopy	Mobile colposcope	patients undergoing colposcopy will have images taken of the cervix with a standard colposcope and the Mobile colposcope. de-identified images from both devices will then be entered into a custom colposcopic image evaluation program. Images will then be randomly evaluated by expert colposcopists as normal, abnormal or cannot evaluate. On abnormal images, the most abnormal point on the images will be marked as teh recommended biopsy site. Scoring for images from the standard colposcope will be compared with that for the Mobile Colposcope.

Primary Outcome Measures

Name	Time	Method
Determine of the smart-phone based cervical imaging device provides non-inferior image to that obtained using a standard culposcope for the detecton of cervical dysplasia	1 day	See above.

Trial Locations

Locations (1)

Scripps Clinic; 🇺🇸 San Diego, California, United States