Colorectal AdenomaNCT07150130
Development and Validation of an Artificial Intelligence-assisted System for Bowel Cleanliness Assessment Based on Withdrawal Distance Weighting
An observational study of Colorectal Adenoma, run by Fudan University at 1 site in China.
Trial summary
To address the limitations of current AI-based systems that rely on the assumption of a "constant withdrawal speed," this study proposes the integration of the UPD-3 endoscopic positioning system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Adenoma
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Oct 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Colonoscopy images, colonoscopy videos, and colonoscopy videos with the UPD-3 positioning system from the electronic database of our hospital
Who may be able to join
- Clear colonoscopy images suitable for BBPS scoring
- Complete and clear colonoscopy videos suitable for BBPS scoring
- Clear colonoscopy videos with a stable UPD-3 positioning system, without signal drift, disappearance, or other disruptions
Who cannot join
- Blurred colonoscopy images
- Colonoscopy images taken from the small intestine or outside the patient's body
- Colonoscopy images captured during irrigation or instrument manipulation
- Colonoscopy images obtained during chromoendoscopy
- Colonoscopy videos that do not contain the complete withdrawal process
- Videos in which the UPD-3 colonoscopic positioning system exhibited signal drift, disappearance, or other instability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
To address the limitations of current AI-based systems that rely on the assumption of a "constant withdrawal speed," this study proposes the integration of the UPD-3 endoscopic positioning system. By using colonoscope withdrawal videos in combination with UPD-3 imaging data as training samples, we aim to develop an AI-powered bowel cleanliness assessment system that incorporates "withdrawal distance" as a weighting factor. This approach is expected to yield a more reliable, objective, and clinically applicable intelligent assessment system that better aligns with real-world clinical practice and endoscopists' operational habits.
Read the detailed description
This study developed an intelligent bowel cleanliness assessment system that uses colonoscope withdrawal distance as a weighting factor. The system consists of the following four modules:
- Module 1: Exclusion of Unqualified Frames in Colonoscopy Videos 1.1 A total of 20 randomly selected colonoscope withdrawal videos (from 20 different subjects) were retrospectively collected from the Endoscopy Center database of Huadong Hospital between January 2018 and June 2024. Images were extracted at a rate of 5 frames per second. Clear frames suitable for BBPS scoring and unqualified frames (e.g., blurred, under irrigation, with instrument manipulation, images from the small intestine, outside the patient, or chromoendoscopy images) were manually labeled. 1.2 The labeled images were split into training and validation sets at a 7:3 ratio. A Transformer-based AI classification model was trained on the training set and validated on the validation set. 1.3 An additional 10 independent colonoscope withdrawal videos (from 10 different subjects) were retrospectively collected using the same method for image extraction and manual labeling. These served as an external validation set to assess the accuracy of the AI model in classifying qualified vs. unqualified frames, thereby evaluating its clinical applicability.
- Module 2: BBPS 0-3 Scoring for Qualified Colonoscopy Images 2.1 Colonoscopy images were randomly collected from the same database between January 2018 and June 2024. Three expert endoscopists (with over 5 years of experience) independently assigned BBPS scores (0-3) to each image. Images with at least two consistent ratings were included. Data collection concluded once each of the four categories (BBPS 0-3) had at least 500 labeled images, sourced from at least 500 different subjects. 2.2 The labeled images were split into training and validation sets at a 7:3 ratio. A CLIP-based AI classification model was trained and validated accordingly. 2.3 Ten additional independent withdrawal videos (from 10 different subjects) were retrospectively collected. Images were extracted at 1 frame per second and manually labeled with BBPS 0-3 scores. These were used as an external validation set to evaluate the model's BBPS classification accuracy and clinical relevance. 2.4 Human-Machine Contest: A set of 120 colonoscopy images (30 for each BBPS score 0-3), labeled by three expert endoscopists, were retrospectively selected (from at least 30 different subjects). The AI system, two junior endoscopists (<5 years of experience), and two expert endoscopists (>5 years of experience) independently assigned BBPS scores to all 120 images. The accuracy of the AI system was compared with that of the junior and expert endoscopists.
- Module 3: Prediction of Hepatic and Splenic Flexure Locations 3.1 Forty colonoscope withdrawal videos (from 40 different subjects) containing UPD-3 positioning data were collected. An expert endoscopist used the UPD-3 system and the video to identify and extract 5-15s video clips representing the transition through the hepatic flexure (ascending to transverse colon) and the splenic flexure (transverse to descending colon). 3.2 These 40 videos were split into training and validation sets at a 3:1 ratio. For training, the 5-15s clips representing flexure transitions, along with 5s of video before and after the clip, were used to train a Video-LLaMA-based AI model. In the validation set, the model predicted flexure transition clips, and its consistency with expert annotations was measured. Manual verification of whether predicted clips contained the actual transition process was also performed to compute accuracy. 3.3 Human-Machine Contest: Ten independent colonoscope withdrawal videos (from 10 different subjects) with UPD-3 positioning were collected. The UPD-3 overlay was masked, and the AI system, two junior endoscopists, and two expert endoscopists were asked to extract 10s clips they believed represented transitions through the hepatic and splenic flexures. An expert endoscopist then used the UPD-3 data and the videos to judge whether each 10s clip indeed included the respective transition, comparing the accuracy among the AI system, junior, and expert endoscopists.
- Module 4: Real-Time Prediction of Withdrawal Distance
4.1 Dataset Construction: Video segments were randomly sampled from full withdrawal videos. OCR technology was used to extract real-time insertion depth values displayed by the UPD-3 system. The difference in length between the first and last frame was recorded as the ground truth label. Segments were manually screened to exclude invalid clips, ensuring a final dataset of over 2,000 valid segments covering a range of lengths and withdrawal distances.
4.2 Teacher Model Training: The teacher model consists of a 3D feature extractor (3D-GAN) and a video feature extractor (Transformer). The model estimates withdrawal distance using UPD-3 imaging and video clips. The 3D-GAN extracts features from multi-view UPD-3 images, and the Transformer extracts video features. The 3D features guide the training of the Transformer to predict withdrawal distance.
4.3 Student Model Training via Knowledge Distillation: The student model consists of a single Transformer trained using video-only inputs. It learns from the teacher model through knowledge distillation to improve its prediction accuracy without access to 3D data during inference.
4.4 Model Validation: The student model was evaluated using the validation set, using only video input (no 3D data) to better reflect real-world deployment. Accuracy was measured by computing the mean squared error between predicted and actual withdrawal distances.
- Conditions
- Colorectal Adenoma
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Adenoma detection rate, Bowel preparation assessment, Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| Cohort for Module 1 | Development and Validation of Module for Exclusion of Unqualified Frames in Colonoscopy Videos Receives: Other: No Intervention: Observational Cohort | |
| Cohort for Module 2 | Development and Validation of Module for BBPS 0-3 Scoring for Qualified Colonoscopy Images Receives: Other: No Intervention: Observational Cohort | |
| Cohort for Module 3 | Development and Validation of Module for Prediction of Hepatic and Splenic Flexure Locations Receives: Other: No Intervention: Observational Cohort | |
| Cohort for Module 4 | Development and Validation of Module for Real-Time Prediction of Withdrawal Distance Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction accuracy of the models
Measured: Immediately after models development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Danian Ji, M.D., Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150130
- Sponsor's protocol ID
- 2024K272-F251
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Artificial Intelligence-assisted System for Bowel Cleanliness Assessment Based on Withdrawal Distance Weighting
- ClinicalTrials.gov ID
- NCT07150130
- Acronym / sponsor ID
- 2024K272-F251
- Conditions
- Colorectal Adenoma
- Keywords
- Adenoma detection rate, Bowel preparation assessment, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 2 Sep 2025 (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.
To address the limitations of current AI-based systems that rely on the assumption of a "constant withdrawal speed," this study proposes the integration of the UPD-3 endoscopic positioning system. By using colonoscope withdrawal videos in combination with UPD-3 imaging data as training samples, we aim to develop an AI-powered bowel cleanliness assessment system that incorporates "withdrawal distance" as a weighting factor. This approach is expected to yield a more reliable, objective, and clinically applicable intelligent assessment system that better aligns with real-world clinical practice and endoscopists' operational habits.
Detailed description
This study developed an intelligent bowel cleanliness assessment system that uses colonoscope withdrawal distance as a weighting factor. The system consists of the following four modules:
- Module 1: Exclusion of Unqualified Frames in Colonoscopy Videos 1.1 A total of 20 randomly selected colonoscope withdrawal videos (from 20 different subjects) were retrospectively collected from the Endoscopy Center database of Huadong Hospital between January 2018 and June 2024. Images were extracted at a rate of 5 frames per second. Clear frames suitable for BBPS scoring and unqualified frames (e.g., blurred, under irrigation, with instrument manipulation, images from the small intestine, outside the patient, or chromoendoscopy images) were manually labeled. 1.2 The labeled images were split into training and validation sets at a 7:3 ratio. A Transformer-based AI classification model was trained on the training set and validated on the validation set. 1.3 An additional 10 independent colonoscope withdrawal videos (from 10 different subjects) were retrospectively collected using the same method for image extraction and manual labeling. These served as an external validation set to assess the accuracy of the AI model in classifying qualified vs. unqualified frames, thereby evaluating its clinical applicability.
- Module 2: BBPS 0-3 Scoring for Qualified Colonoscopy Images 2.1 Colonoscopy images were randomly collected from the same database between January 2018 and June 2024. Three expert endoscopists (with over 5 years of experience) independently assigned BBPS scores (0-3) to each image. Images with at least two consistent ratings were included. Data collection concluded once each of the four categories (BBPS 0-3) had at least 500 labeled images, sourced from at least 500 different subjects. 2.2 The labeled images were split into training and validation sets at a 7:3 ratio. A CLIP-based AI classification model was trained and validated accordingly. 2.3 Ten additional independent withdrawal videos (from 10 different subjects) were retrospectively collected. Images were extracted at 1 frame per second and manually labeled with BBPS 0-3 scores. These were used as an external validation set to evaluate the model's BBPS classification accuracy and clinical relevance. 2.4 Human-Machine Contest: A set of 120 colonoscopy images (30 for each BBPS score 0-3), labeled by three expert endoscopists, were retrospectively selected (from at least 30 different subjects). The AI system, two junior endoscopists (<5 years of experience), and two expert endoscopists (>5 years of experience) independently assigned BBPS scores to all 120 images. The accuracy of the AI system was compared with that of the junior and expert endoscopists.
- Module 3: Prediction of Hepatic and Splenic Flexure Locations 3.1 Forty colonoscope withdrawal videos (from 40 different subjects) containing UPD-3 positioning data were collected. An expert endoscopist used the UPD-3 system and the video to identify and extract 5-15s video clips representing the transition through the hepatic flexure (ascending to transverse colon) and the splenic flexure (transverse to descending colon). 3.2 These 40 videos were split into training and validation sets at a 3:1 ratio. For training, the 5-15s clips representing flexure transitions, along with 5s of video before and after the clip, were used to train a Video-LLaMA-based AI model. In the validation set, the model predicted flexure transition clips, and its consistency with expert annotations was measured. Manual verification of whether predicted clips contained the actual transition process was also performed to compute accuracy. 3.3 Human-Machine Contest: Ten independent colonoscope withdrawal videos (from 10 different subjects) with UPD-3 positioning were collected. The UPD-3 overlay was masked, and the AI system, two junior endoscopists, and two expert endoscopists were asked to extract 10s clips they believed represented transitions through the hepatic and splenic flexures. An expert endoscopist then used the UPD-3 data and the videos to judge whether each 10s clip indeed included the respective transition, comparing the accuracy among the AI system, junior, and expert endoscopists.
- Module 4: Real-Time Prediction of Withdrawal Distance
4.1 Dataset Construction: Video segments were randomly sampled from full withdrawal videos. OCR technology was used to extract real-time insertion depth values displayed by the UPD-3 system. The difference in length between the first and last frame was recorded as the ground truth label. Segments were manually screened to exclude invalid clips, ensuring a final dataset of over 2,000 valid segments covering a range of lengths and withdrawal distances.
4.2 Teacher Model Training: The teacher model consists of a 3D feature extractor (3D-GAN) and a video feature extractor (Transformer). The model estimates withdrawal distance using UPD-3 imaging and video clips. The 3D-GAN extracts features from multi-view UPD-3 images, and the Transformer extracts video features. The 3D features guide the training of the Transformer to predict withdrawal distance.
4.3 Student Model Training via Knowledge Distillation: The student model consists of a single Transformer trained using video-only inputs. It learns from the teacher model through knowledge distillation to improve its prediction accuracy without access to 3D data during inference.
4.4 Model Validation: The student model was evaluated using the validation set, using only video input (no 3D data) to better reflect real-world deployment. Accuracy was measured by computing the mean squared error between predicted and actual withdrawal distances.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort for Module 1 | – | Other: No Intervention: Observational CohortDevelopment and Validation of Module for Exclusion of Unqualified Frames in Colonoscopy Videos |
| Cohort for Module 2 | – | Other: No Intervention: Observational CohortDevelopment and Validation of Module for BBPS 0-3 Scoring for Qualified Colonoscopy Images |
| Cohort for Module 3 | – | Other: No Intervention: Observational CohortDevelopment and Validation of Module for Prediction of Hepatic and Splenic Flexure Locations |
| Cohort for Module 4 | – | Other: No Intervention: Observational CohortDevelopment and Validation of Module for Real-Time Prediction of Withdrawal Distance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Colonoscopy images, colonoscopy videos, and colonoscopy videos with the UPD-3 positioning system from the electronic database of our hospital
Key inclusion criteria (3 listed)
- Clear colonoscopy images suitable for BBPS scoring
- Complete and clear colonoscopy videos suitable for BBPS scoring
- Clear colonoscopy videos with a stable UPD-3 positioning system, without signal drift, disappearance, or other disruptions
Key exclusion criteria (6 listed)
- Blurred colonoscopy images
- Colonoscopy images taken from the small intestine or outside the patient's body
- Colonoscopy images captured during irrigation or instrument manipulation
- Colonoscopy images obtained during chromoendoscopy
- Colonoscopy videos that do not contain the complete withdrawal process
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 |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | Cohort for Module 1, Cohort for Module 2, Cohort for Module 3, Cohort for Module 4 |
Primary outcome
Prediction accuracy of the models
Time frame: Immediately after models development
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 2 Sep 2025.
- 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.
Danian Ji, M.D. study director
Huadong Hospital
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 Colorectal Adenoma, run by Fudan University at 1 site in China.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Sep 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 China. 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 Danian Ji, M.D. (+86-18019094606, arctg4@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction accuracy of the models (time frame: Immediately after models development). 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 2 Sep 2025.