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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05388162

Enrollment

Registered

2022-05-24

Start date

2014-11-30

Completion date

2016-03-31

Last updated

2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Cervical cancer screening,colposcopy,smartphone

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.

Interventions

DEVICEMobile colposcope

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

none \-

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026