Interpretation of Endoscopic Characteristics of Colorecta... | NCT03569124

Studies
Interpretation of Endoscopic Characteristics of Colorectal Polyps With Blue Light Imaging

NCT03569124

Sponsor

Midwest Biomedical Research Foundation

Status

Unknown status

Last Update Posted

Mar 16, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Identification of Colorectal Polyps

Interventions

Teaching tool for identification of colorectal polyps

Countries

Not provided

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Estimated

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jun 14, 2018

First Submission Date that Met QC Criteria

Jun 14, 2018

First Posted Date

Jun 26, 2018Actual

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

Mar 15, 2023

Last Update Posted Date

Mar 16, 2023Actual

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

Interpretation of endoscopic characteristics of colorectal polyps with Blue Light Imaging A study of BLI images and videos of colorectal polyps will be presented initially as a training set followed by with explanation and teaching in a didactic session to two separate groups. A post-test will be conducted to look at the quality of the learning experience.

To evaluate the teaching tool regarding the criteria for BLI images of colorectal polyps by the following measures

Inter-observer agreement between same and different groups
Accuracy in describing the morphology of colorectal polyps • This new teaching tool will improve
Inter-observer agreement by at least 5%- 10% (depending on the group)
Accuracy by at least 5%- 10% (depending on the group)• To determine the improvement of inter-observer agreement in identifying/ describing colorectal polyps after the didactic session in both the groups
Overall Accuracy, Sensitivity, Specificity, Positive predictive value and negative predictive value pre-and post-test in both the groups

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training group			Other: Teaching tool for identification of colorectal polyps
Non-Training group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Teaching tool for identification of colorectal polyps	Other	This is a teaching session on how to identify the colorectal polyps shot in blue light imaging.	Training group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
inter-observer agreement in identifying/ describing colorectal polyps	it is measured by kappa statistic which measures the agreements of the total interpretations	1 year

Secondary Outcomes

Measure	Description	Time Frame
Accuracy	Accuracy comparison between training and non training groups	1 year
Sensitivity	Sensitivity comparison between training and non training groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria All gastroenterology attending physicians, gastroenterology fellows, residents and medical students at the VA medical center

Exclusion Criteria Not willing to participate H/O colour blindness or visual impairment Any intellectual disability

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Study participants are contacted while they are at the VA medical centre. All gastroenterology attending physicians, gastroenterology fellows, residents and medical students will be notified about the study and asked about the willingness to participate if they fit the inclusion/exclusion criteria. Practicing gastroenterologists and trainees will be contacted and inquired about their intent of participating in the assessment of images/videos. This is a voluntary project and not a part of any mandatory training. There is no coercion of participants who do not want to participate.

This study includes only the images and videos from standard pre-existing database. This database was developed by European investigators for educational purposes. This information has no patient identifiable parameters. This information is stored in a secure server with guarded access.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22609383	Background	Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.
19584829	Background