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

Gastric Varix Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614999
• Other study ID #: 3741
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2022
• Source: Mahidol University
• Contact: Sarunpron Kamolvisit, MD
• Phone: 0838511119
• Email: aaeaazpy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric Varix
• Varicose Veins

Intervention

Other:
• Endoscopy training curriculum
Eight sessions training in endoscopic tip control using Varix trainer model I.

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor skill for endoscopic tip control improvement VS control	Speed of pointing to 20 numbers using Varix trainer model I	4-6 weeks
Secondary	Motor skill for endoscopic tip control 1st year fellow trainee VS 2nd year fellow trainee VS expert	Speed of pointing to 20 numbers using Varix trainer model I	4-6 weeks