Back to resultsThe Validation and Efficacy of Varix Trainer as a Training Device Esophagogastroduodenoscopy (a Multicenter Study)
Primary Purpose
Gastric Varix
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Endoscopy training curriculum
Sponsored by
About this trial
This is an interventional other trial for Gastric Varix focused on measuring Endoscopy training, Gastroscopy, Tip control, Motor skill
Eligibility Criteria
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 Expert (> 1,500 EGD) Trainees (First and second year fellow) Exclusion Criteria: Deny to participate in our study
Sites / Locations
- Ramathibodi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Training group
Non-training group
Arm Description
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.
Participants in this group will do the pre-training test, and then do the post-training test after the pre-test 4-6weeks.
Outcomes
Primary Outcome Measures
Motor skill for endoscopic tip control improvement VS control
Speed of pointing to 20 numbers using Varix trainer model I
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05614999
Brief Title
The Validation and Efficacy of Varix Trainer as a Training Device Esophagogastroduodenoscopy (a Multicenter Study)
Official Title
The Validation and Efficacy of Varix Trainer as a Training Device Esophagogastroduodenoscopy (a Multicenter Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2022 (Anticipated)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Varix
Keywords
Endoscopy training, Gastroscopy, Tip control, Motor skill
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-training group
Arm Type
No Intervention
Arm Description
Participants in this group will do the pre-training test, and then do the post-training test after the pre-test 4-6weeks.
Intervention Type
Other
Intervention Name(s)
Endoscopy training curriculum
Intervention Description
Eight sessions training in endoscopic tip control using Varix trainer model I.
Primary Outcome Measure Information:
Title
Motor skill for endoscopic tip control improvement VS control
Description
Speed of pointing to 20 numbers using Varix trainer model I
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
Motor skill for endoscopic tip control 1st year fellow trainee VS 2nd year fellow trainee VS expert
Description
Speed of pointing to 20 numbers using Varix trainer model I
Time Frame
4-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Expert (> 1,500 EGD)
Trainees (First and second year fellow)
Exclusion Criteria:
Deny to participate in our study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarunpron Kamolvisit, MD
Phone
0838511119
Email
aaeaazpy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Taya Kitiyakara, MBBS
Phone
086-887-0491
Email
tayakiti@gmail.com
Facility Information:
Facility Name
Ramathibodi Hospital
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarunporn Kamolvisit, MD
Phone
0838511119
Email
aaeaazpy@gmail.com
First Name & Middle Initial & Last Name & Degree
Taya Kitiyakara, MBBS
Phone
086-887-0491
Email
tayakiti@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Validation and Efficacy of Varix Trainer as a Training Device Esophagogastroduodenoscopy (a Multicenter Study)
We'll reach out to this number within 24 hrs