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

NCT ID: NCT05614999

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-06

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Varix

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Endoscopy training curriculum

Intervention Type OTHER

Eight sessions training in endoscopic tip control using Varix trainer model I.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endoscopy training curriculum

Eight sessions training in endoscopic tip control using Varix trainer model I.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ramathibodi Hospital

Ratchathewi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Sarunpron Kamolvisit, MD

Role: CONTACT

0838511119

Taya Kitiyakara, MBBS

Role: CONTACT

086-887-0491

Facility Contacts

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Sarunporn Kamolvisit, MD

Role: primary

0838511119

Taya Kitiyakara, MBBS

Role: backup

086-887-0491

Other Identifiers

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3741

Identifier Type: -

Identifier Source: org_study_id

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