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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: Completed NA study, sponsored by Scripps Health.
NCT05388162 is a NA study that has completed, run by Scripps Health. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
See above.
Interventions
- DEVICE Mobile colposcope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-03 |
| Phase | NA |
What the finished NCT05388162 record still lists
NCT05388162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Mobile colposcope is the first listed.
NCT05388162 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05388162's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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