UZ Ghent
Ghent, East-Flanders, 9000, Belgium
Location status: Recruiting
Recruiting
NCT Number: NCT07609017
Assessment of Endoscopic Tip Control Using a Novel Score Based on Snare Tip Soft Coagulation of ex Vivo Model (HAM STUDY)
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.
Recruiting
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Request InfoKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Study Endpoints: Primary endpoints include correlating STSC accuracy and speed with endoscopist expertise profiles, defining expected tip control ranges, and assessing agreement between raters. Secondary endpoints focus on evaluating improvement in tip control following training.
Methods: A prospective trial will be conducted, involving endoscopists of varying experience levels.
Participants will undergo assessments while performing STSC on the margin of a line within an ex vivo model to simulate a polypectomy defect. The assessments will be video-recorded and anonymized. After the first assessment, the participants will perform a tip control training session on the model before each subsequent assessment. A total of four assessments and three training sessions will be performed. An online application will be used by a pool of 6 expert raters to anonymously rate the videos of the STSC application and calculate the accuracy (number of correct hits over number of wrong hits) and the speed (hits/second) of tip control. No questionaries will be administered to the participants.
Statistical Methods: Statistical analysis will be performed using R software, with data collected and managed in Excel. Pseudonymized data will be stored securely on the hospital server.
Conclusion: This study outlines a comprehensive approach to evaluating endoscopist tip control during STSC application. By developing a standardized assessment tool and conducting a prospective trial, the investigators aim to improve our understanding of tip control proficiency and its implications for endoscopic practice.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Digestive endoscopists at any level of training (trainee, consultant endoscopist, or advanced/interventional endoscopist)
- Signed informed consent for study participation
Exclusion criteria
- No signed informed consent for study participation
Treatment and study plan
Ham-based Assessment Model
ProcedureExposure to the HAM model during self-directed learning.
Primary outcomes
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Speed and accuracy of STSC
Time frame: From baseline STSC assessment (T1) through the final post-training STSC assessment (T4), assessed up to 4 weeks per participant.
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospital, Ghent
Other
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- May 27, 2026
- Registry last updated
- May 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.