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NCT05388162 · ClinicalTrials.gov registry record · NA
A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.
A NA study, sponsored by Scripps Health.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT05388162 is a NA study that has completed, run by Scripps Health. The registered enrollment target is 26 participants.
The verdict
NCT05388162, a NA study, has completed, sponsored by Scripps Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
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
Interventions
- DEVICE Mobile colposcope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05388162
The ClinicalTrials.gov registry entry for NCT05388162 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scripps Health, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mobile colposcope is the first listed.
NCT05388162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05388162 about?
NCT05388162 is a clinical study titled "A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.". 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 be...
What is the current status of trial NCT05388162?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2014-11. Estimated completion is 2016-03.
What interventions are being tested in trial NCT05388162?
The interventions under investigation include: Mobile colposcope (DEVICE).
Who is sponsoring clinical trial NCT05388162?
This trial is sponsored by Scripps Health, which has 30 total clinical trials registered on ClinicalTrials.gov.
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