Evaluating Endoscopist Tip Control During STSC ApplicationNCT07609017
Assessment of Endoscopic Tip Control Using a Novel Score Based on Snare Tip Soft Coagulation of ex Vivo Model (HAM STUDY)
A study testing Ham-based Assessment Model in people with Evaluating Endoscopist Tip Control During STSC Application, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluating Endoscopist Tip Control During STSC Application
- What is being tested?
- Ham-based Assessment Model
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jan 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Digestive endoscopists at any level of training (trainee, consultant endoscopist, or advanced/interventional endoscopist)
- Signed informed consent for study participation
Who cannot join
- No signed informed consent for study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Ghent
Ghent, East-Flanders, 9000
Lynn Deleu, 93321063 ext. +32, lynn.deleu@uzgent.be
About this 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:
Read more
- 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.
Read the 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.
- Being tested
- Ham-based Assessment Model
- Keywords
- endoscopic tip-control, snare tip soft coagulation (STSC) training model, Ham study endoscopy training, endoscopy STSC tip control, Ham study endoscopy tip control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ham-based Assessment ModelProcedure or surgery
Exposure to the HAM model during self-directed learning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ham-based Assessment Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline STSC assessment (T1) through the final post-training STSC assessment (T4), assessed up to 4 weeks per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start8 Jan 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluating Endoscopist Tip Control During STSC ApplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609017
- Sponsor's protocol ID
- ONZ-2024-0214
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared with researchers outside the research group for this study.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endoscopic Tip Control Using a Novel Score Based on Snare Tip Soft Coagulation of ex Vivo Model (HAM STUDY)
- ClinicalTrials.gov ID
- NCT07609017
- Acronym / sponsor ID
- ONZ-2024-0214
- Keywords
- endoscopic tip-control, snare tip soft coagulation (STSC) training model, Ham study endoscopy training, endoscopy STSC tip control, Ham study endoscopy tip control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| STSC training | Experimental | Procedure: Ham-based Assessment ModelA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Digestive endoscopists at any level of training (trainee, consultant endoscopist, or advanced/interventional endoscopist)
- Signed informed consent for study participation
Key exclusion criteria (1 listed)
- No signed informed consent for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ham-based Assessment ModelExposure to the HAM model during self-directed learning. | Procedure or surgery | STSC training |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. Participant data will not be shared with researchers outside the research group for this study.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ham-based Assessment Model in people with Evaluating Endoscopist Tip Control During STSC Application, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynn Deleu (93321063 ext. +32, lynn.deleu@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.