Adenoma Colon PolypNCT06577610
The Impact of a Colonoscopy Monitoring Program on Endoscopists' Performance
A study testing Feedback from colonoscopy monitoring program in people with Adenoma Colon Polyp and Sessile Serrated Adenoma, run by Seoul National University Hospital.
Trial summary
The goal of this clinical trial is to learn if colonoscopy monitoring program works to adenoma detection rate in endoscopists. It will also learn about the impact on sessile serrated lesion detection rate, adenomas per colonoscopy, sessile serrated lesions per colonoscopy, advanced adenoma detection rate. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adenoma Colon Polyp, Sessile Serrated Adenoma
- What is being tested?
- Feedback from colonoscopy monitoring program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Endoscopists with at least 1 year of colonoscopy experience
Who cannot join
- Endoscopists with less than 1 year of colonoscopy experience
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to learn if colonoscopy monitoring program works to adenoma detection rate in endoscopists. It will also learn about the impact on sessile serrated lesion detection rate, adenomas per colonoscopy, sessile serrated lesions per colonoscopy, advanced adenoma detection rate. The main questions it aims to answer are:
Does colonoscopy monitoring program effect on adenoma detection rate in endoscopists?
Participants will:
Receive result of colonoscopy monitoring program or not every 3 months for 1 year
- Conditions
- Adenoma Colon Polyp, Sessile Serrated Adenoma
- Being tested
- Feedback from colonoscopy monitoring program
- Keywords
- adenoma, Sessile Serrated Adenoma, colonoscopy
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback from colonoscopy monitoring programBehavioural
Adenoma detection rate feedback from colonoscopy monitoring programs
| Study group | Role | What they receive |
|---|---|---|
| Feedback group | Experimental | The feedback group will be notified of the colonoscopy performances. Receives: Behavioral: Feedback from colonoscopy monitoring program |
| Control group | No intervention | The control group will not be notified of the colonoscopy performances. |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
the percentage of patients with at least one histologically proven adenoma
Measured: 1 year
Secondary outcomes (4)
sessile serrated lesion detection rate
the percentage of patients with at least one histologically proven sessile serrated lesion
Measured: 1 year
adenomas per colonoscopy
the number of detected adenomas divided by the total number of screening colonoscopies
Measured: 1 year
sessile serrated lesions per colonoscopy
the number of detected sessile serrated lesions divided by the total number of screening colonoscopies
Measured: 1 year
advanced adenoma detection rate
the percentage of patients with at least one histologically proven advanced adenoma
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma Colon PolypStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Jin Chung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577610
- Sponsor's protocol ID
- 2406-162-1549
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Colonoscopy Monitoring Program on Endoscopists' Performance
- ClinicalTrials.gov ID
- NCT06577610
- Acronym / sponsor ID
- 2406-162-1549
- Conditions
- Adenoma Colon Polyp, Sessile Serrated Adenoma
- Keywords
- adenoma, Sessile Serrated Adenoma, colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Aug 2024 (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.
The goal of this clinical trial is to learn if colonoscopy monitoring program works to adenoma detection rate in endoscopists. It will also learn about the impact on sessile serrated lesion detection rate, adenomas per colonoscopy, sessile serrated lesions per colonoscopy, advanced adenoma detection rate. The main questions it aims to answer are:
Does colonoscopy monitoring program effect on adenoma detection rate in endoscopists?
Participants will:
Receive result of colonoscopy monitoring program or not every 3 months for 1 year
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback group | Experimental | Behavioral: Feedback from colonoscopy monitoring programThe feedback group will be notified of the colonoscopy performances. |
| Control group | No intervention | –The control group will not be notified of the colonoscopy performances. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Endoscopists with at least 1 year of colonoscopy experience
Key exclusion criteria (1 listed)
- Endoscopists with less than 1 year of colonoscopy experience
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 |
|---|---|---|
| Feedback from colonoscopy monitoring programAdenoma detection rate feedback from colonoscopy monitoring programs | Behavioural | Feedback group |
Primary outcome
adenoma detection rate
Time frame: 1 year
the percentage of patients with at least one histologically proven adenoma
4 secondary outcomes
sessile serrated lesion detection rate
Time frame: 1 year
adenomas per colonoscopy
Time frame: 1 year
sessile serrated lesions per colonoscopy
Time frame: 1 year
advanced adenoma detection rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback from colonoscopy monitoring program in people with Adenoma Colon Polyp and Sessile Serrated Adenoma, run by Seoul National University Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Kim (82-10-5195-9531, piejung88@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: 1 year). 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 19 Sep 2024.