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

NCT ID: NCT05388162

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-03-31

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

coposcopy

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.

Group Type: OTHER

Mobile colposcope

Intervention Type: DEVICE

It is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe.

Interventions

Mobile colposcope

It is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Scripps Health

OTHER

Sponsor Role: lead

Responsible Party

Bruce Kahn

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce Kahn

Role: PRINCIPAL_INVESTIGATOR

Scripps Clinic

Locations

Scripps Clinic

San Diego, California, United States

Countries

United States

Other Identifiers

Smart-phone based culposcope

Identifier Type: -

Identifier Source: org_study_id