ColonoscopyARTEMISNCT06094270
Artificial-intelligence-based Reporting Technology for Endoscopy Monitoring and Imaging System
An observational study of Colonoscopy, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
Properly documenting withdrawal time in colonoscopy is essential for quality assessment and cost allocation. However, reporting withdrawal time has significant interobserver variability. Additionally, current manual documentation of endoscopic findings is time-consuming and distracting for the physician. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- EndoMind
- Type of treatment
- Medical device
- How many people
- 147 participants
- Where
- 1 siteGermany
- Study dates
- 19 Dec 2023to 27 Mar 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (>18 years) scheduled for screening, surveillance, or diagnostic colonoscopy
Who may be able to join
- Adult patients (>18 years)
- Scheduled for colonoscopy
Who cannot join
- Patient / Examination level
- Inflammatory Bowel Disease
- Familial Polyposis Syndrome
- Patient after radiation/resection of colonic parts
- Data level
- Endoscopic recordings started after beginning of withdrawal.
- Examination recordings stopped before the end of the examination.
- Examinations with corrupt video signal
Trial locations and contacts
1 site in 1 country.
About this study
Properly documenting withdrawal time in colonoscopy is essential for quality assessment and cost allocation. However, reporting withdrawal time has significant interobserver variability. Additionally, current manual documentation of endoscopic findings is time-consuming and distracting for the physician. This trial examines an artificial intelligence based system to determine withdrawal time and create a structured report, including high-quality images (AI) of detected polyps and landmarks.
Read the detailed description
This study aims to compare withdrawal time precision calculated by an AI system with examiner-reported times during colonoscopy, also evaluating endoscopists' satisfaction with the images included in the AI-generated reports. The study will be single-center and endoscopist-blinded, where 138 patients are expected to be recruited, taking polyp detection rates and potential dropouts into consideration. Manual annotation of withdrawal times from examination recordings will establish gold standard annotations. The AI system performs a frame-by-frame analysis of endoscopy recordings, predicting endoscopic findings. Using a rule-based logic, the method calculates withdrawal time for the examination and automatically generates a report for the examination. The study will include consenting adult patients eligible for colonoscopy, excluding those meeting specific criteria.
In this observational study, the withdrawal time for the examinations of all recruited patients is estimated by both the physician and the AI method. The study does not relate to any particular indication, and any patient that is appointed for a colonoscopy and does not meet the exclusion criteria can be recruited. The AI method operates in the background, having no influence on the examination's process, or outcome. The standard procedure requires physicians to estimate the withdrawal time and document it in the examination report. Simultaneously, the proposed AI method also computes the withdrawal time for all patients in the background, without affecting the physician, the examination, or the outcomes of the examination. Importantly, the physician remains blinded to the AI model's output.
To establish the gold standard withdrawal time, manual calculations will be performed using the recorded examination data for all patients. This gold standard is used for evaluating errors in withdrawal time estimation made by both the physician and the AI method. Subsequently, a comparative analysis is conducted to assess the disparities between the physician's estimations and those of the AI method.
Furthermore, the AI method captures characteristic images of anatomical landmarks and notable events, such as polyp resections, during the examination. A panel of certified endoscopists will rigorously evaluate the quality and relevance of these selected images.
- Conditions
- Colonoscopy
- Being tested
- EndoMind
- Keywords
- Withdrawal Time, Medical Report, Colonoscopy, Artificial Intelligence, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoMindDevice
Withdrawal time is calculated and an image report is generated using the EndoMind system.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention arm | All patients within the study are included in the intervention arm: The withdrawal time for the interventions for all patients is documented by the physician and the proposed AI system. Receives: Device: EndoMind |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal time error comparison for colonoscopies using the proposed AI system versus physician estimation
The error between gold standard withdrawal time and the withdrawal time estimated from the proposed AI system and the physician are compared for the same examination.
Measured: Through study completion, an average of 5 months
Secondary outcomes (3)
Image quality satisfaction
A board of endoscopy experts receives the reports generated by the proposed system and evaluate the quality and satisfaction for the images included in the report. Evaluation will be performed on a Likert scale from 1 to 5.
Measured: Through study completion, an average of 5 months
Subgroup analysis for withdrawal time calculation error based on the presence or absence of resections in the examination.
Interventions will be split into two categories, those containing at least one resection and those without any resections.The error between gold standard withdrawal time and the withdrawal time estimated from the proposed AI system and the physician are compared for each subgroups of examinations separately.
Measured: Through study completion, an average of 5 months
Number of examination where withdrawal time could not be determined
Evaluation of the number of examinations where the withdrawal time could not be calculated and the causes.
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start19 Dec 2023
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094270
- Sponsor's protocol ID
- AI03
- Acronym
- ARTEMIS
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2023
- Last updated
- 3 Apr 2025
- 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial-intelligence-based Reporting Technology for Endoscopy Monitoring and Imaging System
- ClinicalTrials.gov ID
- NCT06094270
- Acronym / sponsor ID
- ARTEMIS / AI03
- Conditions
- Colonoscopy
- Keywords
- Withdrawal Time, Medical Report, Colonoscopy, Artificial Intelligence, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 23 Oct 2023 (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.
Properly documenting withdrawal time in colonoscopy is essential for quality assessment and cost allocation. However, reporting withdrawal time has significant interobserver variability. Additionally, current manual documentation of endoscopic findings is time-consuming and distracting for the physician. This trial examines an artificial intelligence based system to determine withdrawal time and create a structured report, including high-quality images (AI) of detected polyps and landmarks.
Detailed description
This study aims to compare withdrawal time precision calculated by an AI system with examiner-reported times during colonoscopy, also evaluating endoscopists' satisfaction with the images included in the AI-generated reports. The study will be single-center and endoscopist-blinded, where 138 patients are expected to be recruited, taking polyp detection rates and potential dropouts into consideration. Manual annotation of withdrawal times from examination recordings will establish gold standard annotations. The AI system performs a frame-by-frame analysis of endoscopy recordings, predicting endoscopic findings. Using a rule-based logic, the method calculates withdrawal time for the examination and automatically generates a report for the examination. The study will include consenting adult patients eligible for colonoscopy, excluding those meeting specific criteria.
In this observational study, the withdrawal time for the examinations of all recruited patients is estimated by both the physician and the AI method. The study does not relate to any particular indication, and any patient that is appointed for a colonoscopy and does not meet the exclusion criteria can be recruited. The AI method operates in the background, having no influence on the examination's process, or outcome. The standard procedure requires physicians to estimate the withdrawal time and document it in the examination report. Simultaneously, the proposed AI method also computes the withdrawal time for all patients in the background, without affecting the physician, the examination, or the outcomes of the examination. Importantly, the physician remains blinded to the AI model's output.
To establish the gold standard withdrawal time, manual calculations will be performed using the recorded examination data for all patients. This gold standard is used for evaluating errors in withdrawal time estimation made by both the physician and the AI method. Subsequently, a comparative analysis is conducted to assess the disparities between the physician's estimations and those of the AI method.
Furthermore, the AI method captures characteristic images of anatomical landmarks and notable events, such as polyp resections, during the examination. A panel of certified endoscopists will rigorously evaluate the quality and relevance of these selected images.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention arm | – | Device: EndoMindAll patients within the study are included in the intervention arm: The withdrawal time for the interventions for all patients is documented by the physician and the proposed AI system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>18 years) scheduled for screening, surveillance, or diagnostic colonoscopy
Key inclusion criteria (2 listed)
- Adult patients (>18 years)
- Scheduled for colonoscopy
Key exclusion criteria (8 listed)
- Patient / Examination level
- Inflammatory Bowel Disease
- Familial Polyposis Syndrome
- Patient after radiation/resection of colonic parts
- Data level
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 |
|---|---|---|
| EndoMindWithdrawal time is calculated and an image report is generated using the EndoMind system. | Device | Experimental: Intervention arm |
Primary outcome
Withdrawal time error comparison for colonoscopies using the proposed AI system versus physician estimation
Time frame: Through study completion, an average of 5 months
The error between gold standard withdrawal time and the withdrawal time estimated from the proposed AI system and the physician are compared for the same examination.
3 secondary outcomes
Image quality satisfaction
Time frame: Through study completion, an average of 5 months
Subgroup analysis for withdrawal time calculation error based on the presence or absence of resections in the examination.
Time frame: Through study completion, an average of 5 months
Number of examination where withdrawal time could not be determined
Time frame: Through study completion, an average of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Wuerzburg University Hospital at 1 site in Germany.
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 8 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: finished, as of the sponsor's last update on 3 Apr 2025. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Withdrawal time error comparison for colonoscopies using the proposed AI system versus physician estimation (time frame: Through study completion, an average of 5 months). 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 3 Apr 2025.