Back to resultsA Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile colposcope
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer focused on measuring Cervical cancer screening,colposcopy,smartphone
Eligibility Criteria
Inclusion Criteria: adult women with abnormal pap smear or HPV virus testing referred for culposcopy -
Exclusion Criteria: none
-
Sites / Locations
- Scripps Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
coposcopy
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05388162
Brief Title
A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.
Official Title
Smart-phone Based Cervical Imaging Device Compared With a Standard Culposcope for the Detection of Cervical Dysplasia A Non-inferiority Evaluation.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical cancer screening,colposcopy,smartphone
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
coposcopy
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mobile colposcope
Intervention Description
It is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe.
Primary Outcome Measure Information:
Title
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
Description
See above.
Time Frame
1 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult women with abnormal pap smear or HPV virus testing referred for culposcopy -
Exclusion Criteria: none
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Kahn
Organizational Affiliation
Scripps Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.
We'll reach out to this number within 24 hrs