Cervical CancerNCT05388162
A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.
A study testing Mobile colposcope in people with Cervical Cancer, run by Scripps Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Mobile colposcope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smart-phone Based Cervical Imaging Device Compared With a Standard Culposcope for the Detection of Cervical Dysplasia A Non-inferiority Evaluation.
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
Read the detailed description
See above.
- Conditions
- Cervical Cancer
- Being tested
- Mobile colposcope
- Keywords
- Cervical cancer screening,colposcopy,smartphone
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile colposcopeDevice
It is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe.
| Study group | Role | What they receive |
|---|---|---|
| coposcopy | Other | 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. Receives: Device: Mobile colposcope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study startNov 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Kahn, Scripps Health
- Investigators
- Bruce Kahn, Principal investigator, Scripps Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388162
- Sponsor's protocol ID
- Smart-phone based culposcope
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2015
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart-phone Based Cervical Imaging Device Compared With a Standard Culposcope for the Detection of Cervical Dysplasia A Non-inferiority Evaluation.
- ClinicalTrials.gov ID
- NCT05388162
- Acronym / sponsor ID
- Smart-phone based culposcope
- Conditions
- Cervical Cancer
- Keywords
- Cervical cancer screening,colposcopy,smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coposcopy | Other | Device: Mobile colposcopepatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile colposcopeIt is a comparison trial - Comparing a standard colposcpoe with a smart-phone based colpsocpe. | Device | coposcopy |
Primary outcome
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
Time frame: 1 day
See above.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Kahn principal investigator
Scripps Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile colposcope in people with Cervical Cancer, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.