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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07609017
Enrollment
71
Registered
2026-05-27
Start date
2024-01-08
Completion date
2027-06-30
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed description

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.

Interventions

PROCEDUREHam-based Assessment Model

Exposure to the HAM model during self-directed learning.

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

At least two blinded expert endoscopists will score each video to ensure uniform and unbiased judgment of the participants' technical performance.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Speed and accuracy of STSCFrom 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.

Countries

Belgium

Contacts

CONTACTLynn Deleu
lynn.deleu@uzgent.be93321063

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026