A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.
Completed · Not applicable
Conditions studied: Cervical Cancer
In brief
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
Key facts
- Study ID
- NCT05388162
- Run by
- Scripps Health
- People needed
- 26
- Starts
- 2014-11-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2022-11-22
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.
Where it is running
- Scripps Clinic — San Diego, California, United States
Full record on ClinicalTrials.gov
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