Colposcopy Education Using Operant Learning | NCT04340011

Studies
Colposcopy Education Using Operant Learning

NCT04340011

Sponsor

University of Virginia

Status

Unknown status

Last Update Posted

Apr 24, 2020Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Educational Problems
Cervix, Dysplasia

Interventions

Colposcopy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Feb 1, 2021Estimated

Completion Date

Feb 1, 2022Estimated

First Submitted Date

Jan 13, 2020

First Submission Date that Met QC Criteria

Apr 6, 2020

First Posted Date

Apr 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2020

Last Update Posted Date

Apr 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colposcopy	Other	prospective resident education for colposcopy		prospective resident education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ability to give informed consent
age 21or older
undergoing clinically indicated colposcopy

Exclusion Criteria:

under 21 years of age

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

colposcopy only performed in female population

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Females over the age of 21 undergoing clinically indicated coposcopy that are able to give informed consent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ian C Cook, MD	Contact	4349821719		ic8ft@hscmail.mcc.virginia.edu

Overall Officials

Name	Affiliation	Role
Leigh Cantrell, MD	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy of Virginia	Recruiting	Charlottesville	Virginia	22903	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Once pathology is confirmed 3-4 weeks post colposcopy all PHI will be removed from the participant

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002578	Uterine Cervical Dysplasia

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003127	Colposcopy

Ancestor Terms

ID	Term
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided