Educational ProblemsColpoNCT04340011
Colposcopy Education Using Operant Learning
An observational study of Educational Problems and Cervix, Dysplasia, run by University of Virginia at 1 site in United States.
Trial summary
Images will be collected during routine colposcopy and paired with their pathology results to be used for resident education Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Educational Problems, Cervix, Dysplasia
- What is being tested?
- Colposcopy
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 1 Feb 2022
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Females over the age of 21 undergoing clinically indicated coposcopy that are able to give informed consent
Who may be able to join
- ability to give informed consent
- age 21or older
- undergoing clinically indicated colposcopy
Who cannot join
- under 21 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Univeristy of Virginia
Charlottesville, Virginia, 22903
Ian Cook, MD
Ian Cook, MD
About this study
Images will be collected during routine colposcopy and paired with their pathology results to be used for resident education
Read the detailed description
Identifying information will be removed and operant learning techniques will be applied to better educate residents on colposcopy.
- Conditions
- Educational Problems, Cervix, Dysplasia
- Being tested
- Colposcopy
- Keywords
- colposcopy, resident education
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColposcopyOther
Also called prospective resident education
prospective resident education for colposcopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Resident accuracy in identifying sites for biopsy during Colposcopy
using colposcopic images obtained during routine patient care residents will complete quiz from images with immediate results of the test to assess the accuracy of visual cues to biopsy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Apr 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Cantrell, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340011
- Sponsor's protocol ID
- 22034
- Acronym
- Colpo
- Status last verified
- Apr 2020
- First submitted
- 13 Jan 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once pathology is confirmed 3-4 weeks post colposcopy all PHI will be removed from the participant
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colposcopy Education Using Operant Learning
- ClinicalTrials.gov ID
- NCT04340011
- Acronym / sponsor ID
- Colpo / 22034
- Conditions
- Educational Problems, Cervix, Dysplasia
- Keywords
- colposcopy, resident education
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 9 Apr 2020 (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.
Images will be collected during routine colposcopy and paired with their pathology results to be used for resident education
Detailed description
Identifying information will be removed and operant learning techniques will be applied to better educate residents on colposcopy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Females over the age of 21 undergoing clinically indicated coposcopy that are able to give informed consent
Key inclusion criteria (3 listed)
- ability to give informed consent
- age 21or older
- undergoing clinically indicated colposcopy
Key exclusion criteria (1 listed)
- under 21 years of age
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 |
|---|---|---|
| ColposcopyAlso: prospective resident educationprospective resident education for colposcopy | Other | – |
Primary outcome
Resident accuracy in identifying sites for biopsy during Colposcopy
Time frame: 1 year
using colposcopic images obtained during routine patient care residents will complete quiz from images with immediate results of the test to assess the accuracy of visual cues to biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No. Once pathology is confirmed 3-4 weeks post colposcopy all PHI will be removed from the participant
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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.
Leigh Cantrell, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Educational Problems and Cervix, Dysplasia, run by University of Virginia 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 3 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian C Cook, MD (4349821719, ic8ft@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resident accuracy in identifying sites for biopsy during Colposcopy (time frame: 1 year). 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 24 Apr 2020.