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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital, Ghent

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Digestive endoscopists at any level of training (trainee, consultant endoscopist, or advanced/interventional endoscopist)

Signed informed consent for study participation

Disqualifiers

No signed informed consent for study participation

Trial design

Design model

Single group

Treatments tested in this trial

  • Ham-based Assessment Model

    Procedure/Surgery

    Exposure to the HAM model during self-directed learning.

Treatment groups

71 Participants
are divided into 1 treatment group
Group A: STSC trainingExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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