The Validation and Efficacy of Varix Trainer as a Training Device Esophagogastroduodenoscopy (a Multicenter Study)

November 7, 2022 updated by: Mahidol University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital
        • Contact:
        • Contact:

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

    1. Expert (> 1,500 EGD)
    2. Trainees (First and second year fellow)

Exclusion Criteria:

  • Deny to participate in our study

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Training group
Participants in this group will do the pre-training test, practicing eight-sessions (each session is approximately 15minutes) and then do the post-training test.
Other: Endoscopy training curriculum
Eight sessions training in endoscopic tip control using Varix trainer model I.
No Intervention: Non-training group
Participants in this group will do the pre-training test, and then do the post-training test after the pre-test 4-6weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor skill for endoscopic tip control improvement VS control
Time Frame: 4-6 weeks
Speed of pointing to 20 numbers using Varix trainer model I
4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor skill for endoscopic tip control 1st year fellow trainee VS 2nd year fellow trainee VS expert
Time Frame: 4-6 weeks
Speed of pointing to 20 numbers using Varix trainer model I
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

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 (Anticipated)

November 6, 2022

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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