The Validation and Efficacy of Varix Trainer as a Training Device Esophagogastroduodenoscopy (a Multicenter Study)
1 other identifier
interventional
30
1 country
1
Brief Summary
The goal of this exploratory validation study is to compare levels of expertise (or non-expertise) between GI fellows and experts with the varix trainer. The main question it aim to answer is: Can the varix trainer distinguish levels of expertise (or non-expertise) between novices and experts for specific skills (torque, small wheel and retroflexion techniques)? Does the training with the varix trainer improves these specific skills of GI fellows? Participants will do the pre-training test, practicing eight-sessions (each session is approximately 15minutes) and then do the post-training test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 6, 2022
CompletedFirst Submitted
Initial submission to the registry
November 7, 2022
CompletedFirst Posted
Study publicly available on registry
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedNovember 14, 2022
November 1, 2022
4 months
November 7, 2022
November 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Motor skill for endoscopic tip control improvement VS control
Speed of pointing to 20 numbers using Varix trainer model I
4-6 weeks
Secondary Outcomes (1)
Motor skill for endoscopic tip control 1st year fellow trainee VS 2nd year fellow trainee VS expert
4-6 weeks
Study Arms (2)
Training group
ACTIVE COMPARATORParticipants in this group will do the pre-training test, practicing eight-sessions (each session is approximately 15minutes) and then do the post-training test.
Non-training group
NO INTERVENTIONParticipants in this group will do the pre-training test, and then do the post-training test after the pre-test 4-6weeks.
Interventions
Eight sessions training in endoscopic tip control using Varix trainer model I.
Eligibility Criteria
You may qualify if:
- We enrolled participants from Ramathibodi hospital King Chulalongkorn Memorial hospital Siriraj hospital Rajavithi hospital Vajira hospital Nanthana-Kriangkrai Chotiwattanaphan Institute of Gastroenterology and Hepatology Srinagarind Hospital
- Expert (\> 1,500 EGD)
- Trainees (First and second year fellow)
You may not qualify if:
- Deny to participate in our study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ramathibodi Hospital
Ratchathewi, Bangkok, 10400, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2022
First Posted
November 14, 2022
Study Start
November 6, 2022
Primary Completion
February 28, 2023
Study Completion
March 31, 2023
Last Updated
November 14, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share