Assessment of Endoscopic Tip Control Using a Novel Score Based on Snare Tip Soft Coagulation of ex Vivo Model (HAM STUDY)

NCT07609017 | Recruiting

• 1 other identifier: ONZ-2024-0214
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Colorectal cancer (CRC) is a significant global health concern, with colonoscopy being the primary screening tool for its detection and treatment. Endoscopic techniques such as snare tip soft coagulation (STSC) play a crucial role in reducing adenoma recurrence post-resection. However, assessing endoscopists' proficiency in tip control during these procedures remains challenging. This study aims to develop and validate a web-based scoring system to objectively evaluate endoscopist tip control during STSC application. Research Questions:

• Can STSC application on an ex vivo model effectively measure endoscopic tip control across different levels of endoscopists' experience?
• Is there a correlation between tip control and endoscopists' polypectomy experience?
• Does tip control vary based on endoscopists' specialization?
• Can training on the STSC model improve endoscopists' tip control?
• Is it feasible to train an AI model using videos scored by expert raters to assess tip control?
• Can tip control be used as an objective measure to predict endoscopists' future performance? Research Hypothesis: The investigators hypothesize that developing a model for easy tip control assessment will enable endoscopists to evaluate their proficiency and track progress. Training on the STSC model will enhance tip control, and cut-offs for tip control derived from preliminary data will be refined through this study.

Conditions

Evaluating Endoscopist Tip Control During STSC Application

Keywords

endoscopic tip-control; snare tip soft coagulation (STSC) training model; Ham study endoscopy training; endoscopy STSC tip control; Ham study endoscopy tip control

Outcome Measures

Primary Outcomes (1)

• Speed and accuracy of STSC

  To check the correlation of the accuracy and speed of STSC with the endoscopist's experience profile, the shape of the figure to which STSC is applied and the endoscopist's specialization. The definition of the expected range of tip control speed and accuracy for the different types of endoscopists. The definition for the cut-offs for extraordinary and poor tip control. An agreement in the STSC score between different reviewers.

  From baseline STSC assessment (T1) through the final post-training STSC assessment (T4), assessed up to 4 weeks per participant.

Study Arms (1)

STSC training

EXPERIMENTAL

A free 3D-printed template with dye shapes is used to mark shapes on ham. Endoscopists will then use a snare through the endoscope channel to trace blue-dyed lines with electrosurgical precision.

Procedure: Ham-based Assessment Model

Interventions

Ham-based Assessment Model PROCEDURE

Exposure to the HAM model during self-directed learning.

STSC training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Digestive endoscopists at any level of training (trainee, consultant endoscopist, or advanced/interventional endoscopist)
• Signed informed consent for study participation

You may not qualify if:

• No signed informed consent for study participation

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

UZ Ghent

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Central Study Contacts

Lynn Deleu

CONTACT

93321063; lynn.deleu@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: At least two blinded expert endoscopists will score each video to ensure uniform and unbiased judgment of the participants' technical performance.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The endoscopist will undergo assessment while performing STSC at the edge of a line within an ex vivo model. They will then undergo training and be asked to perform STSC again thereafter for assessment. At least two blinded expert endoscopists will score each video to ensure uniform and unbiased judgment of the participants' technical performance.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 27, 2026
• Study Start: January 8, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)