- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340011
Colposcopy Education Using Operant Learning (Colpo)
April 21, 2020 updated by: University of Virginia
Images will be collected during routine colposcopy and paired with their pathology results to be used for resident education
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Identifying information will be removed and operant learning techniques will be applied to better educate residents on colposcopy.
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Recruiting
- Univeristy of Virginia
-
Contact:
- Ian Cook, MD
-
Sub-Investigator:
- Ian Cook, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Females over the age of 21 undergoing clinically indicated coposcopy that are able to give informed consent
Description
Inclusion Criteria:
- ability to give informed consent
- age 21or older
- undergoing clinically indicated colposcopy
Exclusion Criteria:
- under 21 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leigh Cantrell, MD, University of Virginia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Anticipated)
February 1, 2021
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
January 13, 2020
First Submitted That Met QC Criteria
April 6, 2020
First Posted (Actual)
April 9, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 22034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Once pathology is confirmed 3-4 weeks post colposcopy all PHI will be removed from the participant
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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