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

• Sponsor: Scripps Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT05388162
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Actual Duration (Months): 16
• Patients Per Site Per Month: 1.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Device: Mobile colposcope	N/A

Detailed Description

See above.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Smart-phone Based Cervical Imaging Device Compared With a Standard Culposcope for the Detection of Cervical Dysplasia A Non-inferiority Evaluation.
• Actual Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Other: coposcopy 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; It is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Exclusion Criteria: none

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Clinic	San Diego	California	United States	92130

Sponsors and Collaborators

• Scripps Health

Investigators

• Principal Investigator: Bruce Kahn, Scripps Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scripps Health
• ClinicalTrials.gov Identifier: NCT05388162
• Other Study ID Numbers: Smart-phone based culposcope
• First Posted: May 24, 2022
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Keywords provided by Scripps Health: Cervical cancer screening,colposcopy,smartphone
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of May 24, 2022