NCT05388162

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

Smart-phone Based Cervical Imaging Device Compared With a Standard Culposcope for the Detection of Cervical Dysplasia A Non-inferiority Evaluation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Scripps Health · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Mobile colposcope	It is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2022-05-24
• Last updated: 2022-11-22

Locations

1 site across 1 country: United States