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

Study Overview
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Brief Summary
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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
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See above.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: Mobile colposcope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult women with abnormal pap smear or HPV virus testing referred for culposcopy - Exclusion Criteria: none -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: coposcopy<br>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. | Device: Mobile colposcope<br>* It is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | See above. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer screening,colposcopy,smartphone