Polyp of ColonVideothequeNCT06822816
Video/Image Library of Endoscopy Procedures for the Development of AI-empowered Endoscopy Quality Reporting and Educational Modules
An observational study of Polyp of Colon and Artificial Intelligence (AI), run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The goal of this observational study is to establish a video/image library dataset of complete endoscopy or partial colonoscopy procedures for patients with rectal cancer or inflammatory bowel disease (IBD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp of Colon, Artificial Intelligence (AI)
- How many people
- 10,000 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2022to 31 Dec 2028
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients presenting at the CHUM for an upper or lower endoscopy will be approached for this study.
Who may be able to join
- ≥ 18 y.o.
- indication of undergoing a screening, surveillance, diagnostic, or therapeutic upper (EGD) or lower (colonoscopy) endoscopy
Who cannot join
- Coagulopathy defined as an elevated INR ≥ 2.5
- Platelet count ≤ 50,000/mm3
- Emergency endoscopy
- Poor general health defined as the American Society of Anesthesiologists physical status class >3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
Samira Hanin, 514-890-8000 ext. 30916, samira.hanin.chum@ssss.gouv.qc.ca
Daniel von Renteln, MD
About this study
Official title: Creation of a Video/Image Library of Annotated Full-length Endoscopy Procedures for the Development of Artificial Intelligence-empowered Endoscopy Quality Reporting and Educational Modules
The goal of this observational study is to establish a video/image library dataset of complete endoscopy or partial colonoscopy procedures for patients with rectal cancer or inflammatory bowel disease (IBD). With this video/image library, the aims are:
- to develop and validate novel AI-empowered solutions to automatically detect and report endoscopy quality metrics
- to develop automated endoscopy reporting solutions, auditing, and educational tools for residents and fellows to enhance their endoscopy skills.
Read more
The hypothesis is that a heterogeneous video/image library will provide:
- comprehensive and robust source material to develop AI models
- real-time quality feedback at the end of an endoscopy procedure.
Read the detailed description
The video/image library will be constructed by prospectively recruiting patients referred for endoscopy procedures for the upper or lower gastrointestinal tract diseases. Patients who have had a screening, surveillance, or diagnostic upper or lower endoscopy recorded as part of a research project at the CHUM will all be invited to participate in this banking.
A qualified and adequately trained study team representative will invite potential study patients to participate during and outpatient clinic visit, or at their arrival in the endoscopy unit on the day of the endoscopy.
Board-certified gastroenterologists, or trainees under supervison, will perform all upper or lower endoscopies at the CHUM. Patients will be prepared for endoscopies according to the most recent guidelines and current standards of care.
The complete or partial endoscopy will be video recorded and the data files will be saved without loss of image quality using Medicapture USB 300 (or equivalent) devices and stored locally in an on-site storage cloud. All videos will be recorded with timestamps burned into the recording. A research assistant will document all relevant informations and annotations during the procedure.
All esophagogastroduodenoscopies (EGDs) will be performed using the high-definition endoscopes. All findings (e.g., lesions, polyps, inflammations), diagnostics, and therapeutic procedures will be documented during EGDs.
The colonoscopies will be performed using high-definition colonoscopes equipped with image-enhanced techniques, or CAD systems, to provide real-time support to endoscopists to detect polyps of all sizes. If required, the endoscopists will be instructed to use white-light and narrow-band imaging to perform optical diagnosis (OD) for all 1-10mm polyps. An OD will first be performed without CADx, then CADx will be used to make a CAD-based OD.
After detecting a polyp and performing ODs, the endoscopists will remove all polyps using standard techniques. Endoscopists will annotate the withdrawal time before initiating a resection, and again when the resection is complete. All biopsy specimens and main polyp specimens will be sent to the institutional pathology laboratories (in separate jars) for histopathology assessments.
- Conditions
- Polyp of Colon, Artificial Intelligence (AI)
- Medical subject headings
- Colonic Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
EGD documented data
For EGD procedures, the following data will be documented: the exact time to reach the GE junction, the diaphragmatic hiatus, body/fondus/antrum of stomach, duodenum, procedural time during EGD, complications (immediate and late: first 24h post-procedure and 14 days post-procedure, respectively), the use of a distal attachment cap, insufflation and desufflation, cardiac retroflexion for facilitating visualization of mucosa during EGD, the use of existing AI platforms that increase lesion detection (CADe) and classification (CADx), the AI classification (autonomous CADx diagnosis), the endoscopists' ODs without CADx, the endoscopists' ODs after seeing the diagnosis from CADx (CADx-assisted diagnosis), the performance of endoscopists (measured with detection rates such as ADR, AADR, SSLDR, PDR, or with detection counts such as APC).
Measured: From enrollment to 14 days post-procedure
Colonoscopy documented data
For colonoscopy procedures, the following data will be documented: the exact time to reach the caecum, caecum intubation, the exact time of the visualisation of each anatomical landmarks, confirmed time of each lesion, ulcer, polyp visualised by the endoscopist, withdrawal time, mucosal inspection time, and complications (immediate and late: 24h post-procedure and 14 days post-procedure, respectively), the use of existing AI platforms that increase lesion detection (CADe) and classification (CADx), the AI classification (autonomous CADx diagnosis), the endoscopists' ODs without CADx, the endoscopists' ODs after seeing the diagnosis from CADx (CADx-assisted diagnosis), the performance of endoscopists (measured with detection rates such as ADR, AADR, SSLDR, PDR, or with detection counts such as APC). In the case of patients with rectal cancer, any active disease, such as tumor recurrence will be documented.
Measured: From enrollment to 14 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start10 Jun 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp of ColonStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822816
- Sponsor's protocol ID
- 2023-10355/22.013
- Other IDs
- 2023
- Acronym
- Videotheque
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in research articles based on this video registry, after de-identification (text, tables, figures and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Video/Image Library of Annotated Full-length Endoscopy Procedures for the Development of Artificial Intelligence-empowered Endoscopy Quality Reporting and Educational Modules
- ClinicalTrials.gov ID
- NCT06822816
- Acronym / sponsor ID
- Videotheque / 2023-10355/22.013
- Conditions
- Polyp of Colon, Artificial Intelligence (AI)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Feb 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.
The goal of this observational study is to establish a video/image library dataset of complete endoscopy or partial colonoscopy procedures for patients with rectal cancer or inflammatory bowel disease (IBD). With this video/image library, the aims are:
- to develop and validate novel AI-empowered solutions to automatically detect and report endoscopy quality metrics
- to develop automated endoscopy reporting solutions, auditing, and educational tools for residents and fellows to enhance their endoscopy skills.
The hypothesis is that a heterogeneous video/image library will provide:
- comprehensive and robust source material to develop AI models
- real-time quality feedback at the end of an endoscopy procedure.
Detailed description
The video/image library will be constructed by prospectively recruiting patients referred for endoscopy procedures for the upper or lower gastrointestinal tract diseases. Patients who have had a screening, surveillance, or diagnostic upper or lower endoscopy recorded as part of a research project at the CHUM will all be invited to participate in this banking.
A qualified and adequately trained study team representative will invite potential study patients to participate during and outpatient clinic visit, or at their arrival in the endoscopy unit on the day of the endoscopy.
Board-certified gastroenterologists, or trainees under supervison, will perform all upper or lower endoscopies at the CHUM. Patients will be prepared for endoscopies according to the most recent guidelines and current standards of care.
The complete or partial endoscopy will be video recorded and the data files will be saved without loss of image quality using Medicapture USB 300 (or equivalent) devices and stored locally in an on-site storage cloud. All videos will be recorded with timestamps burned into the recording. A research assistant will document all relevant informations and annotations during the procedure.
All esophagogastroduodenoscopies (EGDs) will be performed using the high-definition endoscopes. All findings (e.g., lesions, polyps, inflammations), diagnostics, and therapeutic procedures will be documented during EGDs.
The colonoscopies will be performed using high-definition colonoscopes equipped with image-enhanced techniques, or CAD systems, to provide real-time support to endoscopists to detect polyps of all sizes. If required, the endoscopists will be instructed to use white-light and narrow-band imaging to perform optical diagnosis (OD) for all 1-10mm polyps. An OD will first be performed without CADx, then CADx will be used to make a CAD-based OD.
After detecting a polyp and performing ODs, the endoscopists will remove all polyps using standard techniques. Endoscopists will annotate the withdrawal time before initiating a resection, and again when the resection is complete. All biopsy specimens and main polyp specimens will be sent to the institutional pathology laboratories (in separate jars) for histopathology assessments.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients presenting at the CHUM for an upper or lower endoscopy will be approached for this study.
Key inclusion criteria (2 listed)
- ≥ 18 y.o.
- indication of undergoing a screening, surveillance, diagnostic, or therapeutic upper (EGD) or lower (colonoscopy) endoscopy
Key exclusion criteria (4 listed)
- Coagulopathy defined as an elevated INR ≥ 2.5
- Platelet count ≤ 50,000/mm3
- Emergency endoscopy
- Poor general health defined as the American Society of Anesthesiologists physical status class >3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EGD documented data
Time frame: From enrollment to 14 days post-procedure
For EGD procedures, the following data will be documented: the exact time to reach the GE junction, the diaphragmatic hiatus, body/fondus/antrum of stomach, duodenum, procedural time during EGD, complications (immediate and late: first 24h post-procedure and 14 days post-procedure, respectively), the use of a distal attachment cap, insufflation and desufflation, cardiac retroflexion for facilitating visualization of mucosa during EGD, the use of existing AI platforms that increase lesion detection (CADe) and classification (CADx), the AI classification (autonomous CADx diagnosis), the endoscopists' ODs without CADx, the endoscopists' ODs after seeing the diagnosis from CADx (CADx-assisted diagnosis), the performance of endoscopists (measured with detection rates such as ADR, AADR, SSLDR, PDR, or with detection counts such as APC).
Colonoscopy documented data
Time frame: From enrollment to 14 days post-procedure
For colonoscopy procedures, the following data will be documented: the exact time to reach the caecum, caecum intubation, the exact time of the visualisation of each anatomical landmarks, confirmed time of each lesion, ulcer, polyp visualised by the endoscopist, withdrawal time, mucosal inspection time, and complications (immediate and late: 24h post-procedure and 14 days post-procedure, respectively), the use of existing AI platforms that increase lesion detection (CADe) and classification (CADx), the AI classification (autonomous CADx diagnosis), the endoscopists' ODs without CADx, the endoscopists' ODs after seeing the diagnosis from CADx (CADx-assisted diagnosis), the performance of endoscopists (measured with detection rates such as ADR, AADR, SSLDR, PDR, or with detection counts such as APC). In the case of patients with rectal cancer, any active disease, such as tumor recurrence will be documented.
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 11 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in research articles based on this video registry, after de-identification (text, tables, figures and appendices).
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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.
Centre Hospitalier de l'Université de Montréal
Montreal, Canada
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 Polyp of Colon and Artificial Intelligence (AI), run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 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 11 Aug 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 Canada. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EGD documented data (time frame: From enrollment to 14 days post-procedure). The study lists 2 primary outcomes in all. 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 11 Aug 2026.