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

NCT05388162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-11-22

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Mobile colposcope

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

Sponsors & Collaborators

  • Scripps Health

    lead OTHER

Principal Investigators

  • Bruce Kahn · Scripps Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388162 on ClinicalTrials.gov