Colon PolypsNCT06676930
Impact of Artificial Intelligence on Trainee Polyp Miss Rates
A study testing Colonoscopy With Computer-Aided Detection and Colonoscopy without Computer-Aided Detection in people with Colon Polyps and Colonoscopy, run by Northwestern University at 1 site in United States.
Trial summary
Based on prior studies, trainee and practicing gastroenterologists miss pre-cancerous polyps (adenomas and serrated polyps) during colonoscopy. The use of computer-aided detection (CADe) systems, a form of artificial intelligence (AI) has been shown to help identify colorectal lesions for practicing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Polyps, Colonoscopy, Artificial Intelligence (AI)
- What is being tested?
- Colonoscopy With Computer-Aided Detection and Colonoscopy without Computer-Aided Detection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 1 Sep 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients referred for screening or surveillance colonoscopy
Who cannot join
- Patients referred for polypectomy or diagnostic colonoscopy
- Patients with prior right colon surgery
- Prolonged insertion time (>20 minutes)
- Poor bowel preparation (Boston Bowel Preparation Score less than or equal to 6)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Impact of Computer Aided Detection on Trainee Polyp Miss Rates Using a Tandem Colonoscopy Design
Based on prior studies, trainee and practicing gastroenterologists miss pre-cancerous polyps (adenomas and serrated polyps) during colonoscopy. The use of computer-aided detection (CADe) systems, a form of artificial intelligence (AI) has been shown to help identify colorectal lesions for practicing gastroenterologists. However, less is known how AI impacts polyp detection for trainees.
The investigators are conducting a tandem colonoscopy study wherein a portion of the colon is examined first by the trainee and then the attending physician. For each procedure, randomization will occur which will determine whether or not the trainee will utilize AI for their examination of the colon. At the end of the study, the investigators will determine whether AI helps trainees miss fewer polyps during colonoscopy. The investigators will also conduct interviews with trainees to understand how AI impacts colonoscopy training.
Read the detailed description
Quality metrics in colonoscopy are useful in determining endoscopist performance. The adenoma detection rate (ADR) has historically been the primary colonoscopy quality indicator of interest, whereby those with a higher ADR have lower rates of interval colon cancers. Other important parameters include the adenoma miss rate (AMR) and the sessile serrated polyp miss rate (SMR).
The AMR among practicing gastroenterologists is estimated at around 25% based on tandem-colonoscopy studies, while the SMR may be even higher. Prior tandem colonoscopy studies have also shown that gastroenterology trainees have an AMR between 30-41% and an SMR between 56-86%. As missed polyps may grow into colorectal cancers over time, efforts must be dedicated to reducing AMR and SMR.
In 2021, the Food and Drug Administration (FDA) approved the first computer-aided detection (CADe) system, (GI-Genius; Medtronic, Minneapolis, MN) for identifying colorectal lesions in the United States. An initial tandem colonoscopy study among experienced endoscopists using this CADe system showed a reduction in AMR from 32.4% to 15.5%. However, it is unknown whether trainees would have a similar reduction in polyp miss rates.
CADe has been introduced into gastroenterology trainee education in a largely unstructured fashion and trainees' perception of CADe's impact on training is largely unknown. Presently, trainees and attendings complete colonoscopies with and without CADe. It is at the discretion of attendings whether CADe is used for a procedure regardless of whether or not a trainee is involved.
In this single center study, all Northwestern gastroenterology trainees will be invited to participate in the trial. First year gastroenterology trainees will initiate participation after 6 months of endoscopic training (approximately 100 colonoscopies completed). Trainees will be complete an hour-long meeting with the study team. The study protocol will be explained in detail and written informed consent will be obtained from the trainees.
The medical records of patients scheduled for ambulatory screening or surveillance colonoscopy during select endoscopy blocks will be screened in advance for inclusion in the study. Participants will be prospectively enrolled.
On the day of the patient's scheduled colonoscopy, a member of the study team will obtain written informed consent for both the colonoscopy and participation in the research study in a private bay in the pre-endoscopy area. The patient will then be transported to the procedure room and sedated. Sedation method (monitored anesthesia care or moderate sedation) will be determined prior to the scheduled appointment. If the patient is to receive moderate sedation, fentanyl and midazolam will be administered in incremental doses per the standard of care. Once the patient is sedated, the fellow and attending will perform the insertion as is standard for a colonoscopy in which a fellow is participating. Once the cecum is reached, the patient will then be randomized to whether the initial inspection of the right colon by the fellow is performed with or without the assistance of CADe in a 1:1 randomization. The fellow withdrawal (pass #1) will start. The fellow, with or without the use of CADe based on randomization, will identify polyps independently of the attending and remove them with attending assistance as appropriate until they feel that they have performed a complete examination of colonic mucosa from the cecum to the splenic flexure. During pass #1, the supervising attending will not provide verbal cues regarding the identification of colon polyps as would typically occur during colonoscopies performed by a fellow, however, the fellow can request attending assistance at any time. Additionally, the attending will provide standard assistance with insertion and polypectomy techniques. While gastroenterology fellow participation in colonoscopy with attending supervision is standard at an academic medical center, pass #1 will be considered "research" for the purposes of this study as the attending will not be providing verbal cues regarding polyp detection as the purpose of this study is to quantify trainee miss rates independent of attending input.
Once the fellow completes pass #1, the attending physician will reinsert the colonoscope to the cecum and perform a second withdrawal (pass #2) with the assistance of the CADe system. A second proximal withdrawal time for pass #2 will be recorded until the splenic flexure is again reached and the attending feels that the colonic mucosa has been fully examined. Any polyps identified and resected by the attending physician during pass #2 will be considered "missed polyps."
The fellow and attending will then complete the exam from the splenic flexure to the rectum with the assistance of CADe, both providers identifying and resecting polyps as necessary, as is standard when a fellow performs colonoscopy with attending supervision.
- Conditions
- Colon Polyps, Colonoscopy, Artificial Intelligence (AI)
- Being tested
- Colonoscopy With Computer-Aided Detection, Colonoscopy without Computer-Aided Detection
- Keywords
- tandem colonoscopy, randomized controlled trial, adenoma miss rate
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy With Computer-Aided DetectionDevice
Use of Computer-Aided Detection During Colonoscopy
Colonoscopy without Computer-Aided DetectionProcedure or surgery
Colonoscopy without Computer-Aided Detection (AI)
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy with AI | Active comparator | Trainee using AI during colonoscopy inspection Receives: Device: Colonoscopy With Computer-Aided Detection |
| Colonoscopy without AI | Active comparator | Trainee not using AI during colonoscopy inspection Receives: Procedure: Colonoscopy without Computer-Aided Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neoplastic polyp miss rate
Proportion of neoplastic (adenomas or serrated polyps) missed during trainee inspection
Measured: 1 week
Secondary outcomes (2)
Adenoma miss rate
Proportion of adenomas missed during trainee inspection
Measured: 1 week
Serrated polyp miss rate
Proportion of serrated polyps missed during trainee inspection
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start10 Sep 2024
- Primary completion25 Aug 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypsStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajesh Keswani, MD, Principal investigator, Northwestern Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676930
- Sponsor's protocol ID
- STU00221977
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No clear benefit in sharing this data
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Computer Aided Detection on Trainee Polyp Miss Rates Using a Tandem Colonoscopy Design
- ClinicalTrials.gov ID
- NCT06676930
- Acronym / sponsor ID
- STU00221977
- Conditions
- Colon Polyps, Colonoscopy, Artificial Intelligence (AI)
- Keywords
- tandem colonoscopy, randomized controlled trial, adenoma miss rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 6 Nov 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.
Based on prior studies, trainee and practicing gastroenterologists miss pre-cancerous polyps (adenomas and serrated polyps) during colonoscopy. The use of computer-aided detection (CADe) systems, a form of artificial intelligence (AI) has been shown to help identify colorectal lesions for practicing gastroenterologists. However, less is known how AI impacts polyp detection for trainees.
The investigators are conducting a tandem colonoscopy study wherein a portion of the colon is examined first by the trainee and then the attending physician. For each procedure, randomization will occur which will determine whether or not the trainee will utilize AI for their examination of the colon. At the end of the study, the investigators will determine whether AI helps trainees miss fewer polyps during colonoscopy. The investigators will also conduct interviews with trainees to understand how AI impacts colonoscopy training.
Detailed description
Quality metrics in colonoscopy are useful in determining endoscopist performance. The adenoma detection rate (ADR) has historically been the primary colonoscopy quality indicator of interest, whereby those with a higher ADR have lower rates of interval colon cancers. Other important parameters include the adenoma miss rate (AMR) and the sessile serrated polyp miss rate (SMR).
The AMR among practicing gastroenterologists is estimated at around 25% based on tandem-colonoscopy studies, while the SMR may be even higher. Prior tandem colonoscopy studies have also shown that gastroenterology trainees have an AMR between 30-41% and an SMR between 56-86%. As missed polyps may grow into colorectal cancers over time, efforts must be dedicated to reducing AMR and SMR.
In 2021, the Food and Drug Administration (FDA) approved the first computer-aided detection (CADe) system, (GI-Genius; Medtronic, Minneapolis, MN) for identifying colorectal lesions in the United States. An initial tandem colonoscopy study among experienced endoscopists using this CADe system showed a reduction in AMR from 32.4% to 15.5%. However, it is unknown whether trainees would have a similar reduction in polyp miss rates.
CADe has been introduced into gastroenterology trainee education in a largely unstructured fashion and trainees' perception of CADe's impact on training is largely unknown. Presently, trainees and attendings complete colonoscopies with and without CADe. It is at the discretion of attendings whether CADe is used for a procedure regardless of whether or not a trainee is involved.
In this single center study, all Northwestern gastroenterology trainees will be invited to participate in the trial. First year gastroenterology trainees will initiate participation after 6 months of endoscopic training (approximately 100 colonoscopies completed). Trainees will be complete an hour-long meeting with the study team. The study protocol will be explained in detail and written informed consent will be obtained from the trainees.
The medical records of patients scheduled for ambulatory screening or surveillance colonoscopy during select endoscopy blocks will be screened in advance for inclusion in the study. Participants will be prospectively enrolled.
On the day of the patient's scheduled colonoscopy, a member of the study team will obtain written informed consent for both the colonoscopy and participation in the research study in a private bay in the pre-endoscopy area. The patient will then be transported to the procedure room and sedated. Sedation method (monitored anesthesia care or moderate sedation) will be determined prior to the scheduled appointment. If the patient is to receive moderate sedation, fentanyl and midazolam will be administered in incremental doses per the standard of care. Once the patient is sedated, the fellow and attending will perform the insertion as is standard for a colonoscopy in which a fellow is participating. Once the cecum is reached, the patient will then be randomized to whether the initial inspection of the right colon by the fellow is performed with or without the assistance of CADe in a 1:1 randomization. The fellow withdrawal (pass #1) will start. The fellow, with or without the use of CADe based on randomization, will identify polyps independently of the attending and remove them with attending assistance as appropriate until they feel that they have performed a complete examination of colonic mucosa from the cecum to the splenic flexure. During pass #1, the supervising attending will not provide verbal cues regarding the identification of colon polyps as would typically occur during colonoscopies performed by a fellow, however, the fellow can request attending assistance at any time. Additionally, the attending will provide standard assistance with insertion and polypectomy techniques. While gastroenterology fellow participation in colonoscopy with attending supervision is standard at an academic medical center, pass #1 will be considered "research" for the purposes of this study as the attending will not be providing verbal cues regarding polyp detection as the purpose of this study is to quantify trainee miss rates independent of attending input.
Once the fellow completes pass #1, the attending physician will reinsert the colonoscope to the cecum and perform a second withdrawal (pass #2) with the assistance of the CADe system. A second proximal withdrawal time for pass #2 will be recorded until the splenic flexure is again reached and the attending feels that the colonic mucosa has been fully examined. Any polyps identified and resected by the attending physician during pass #2 will be considered "missed polyps."
The fellow and attending will then complete the exam from the splenic flexure to the rectum with the assistance of CADe, both providers identifying and resecting polyps as necessary, as is standard when a fellow performs colonoscopy with attending supervision.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy with AI | Active comparator | Device: Colonoscopy With Computer-Aided DetectionTrainee using AI during colonoscopy inspection |
| Colonoscopy without AI | Active comparator | Procedure: Colonoscopy without Computer-Aided DetectionTrainee not using AI during colonoscopy inspection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients referred for screening or surveillance colonoscopy
Key exclusion criteria (4 listed)
- Patients referred for polypectomy or diagnostic colonoscopy
- Patients with prior right colon surgery
- Prolonged insertion time (>20 minutes)
- Poor bowel preparation (Boston Bowel Preparation Score less than or equal to 6)
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 |
|---|---|---|
| Colonoscopy With Computer-Aided DetectionUse of Computer-Aided Detection During Colonoscopy | Device | Colonoscopy with AI |
| Colonoscopy without Computer-Aided DetectionColonoscopy without Computer-Aided Detection (AI) | Procedure or surgery | Colonoscopy without AI |
Primary outcome
Neoplastic polyp miss rate
Time frame: 1 week
Proportion of neoplastic (adenomas or serrated polyps) missed during trainee inspection
2 secondary outcomes
Adenoma miss rate
Time frame: 1 week
Serrated polyp miss rate
Time frame: 1 week
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 28 Sep 2026.
- Individual participant dataSharing planned: No. No clear benefit in sharing this data
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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.
Rajesh Keswani, MD principal investigator
Northwestern Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy With Computer-Aided Detection and Colonoscopy without Computer-Aided Detection in people with Colon Polyps and Colonoscopy, run by Northwestern University at 1 site in United States.
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 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: finished, as of the sponsor's last update on 28 Sep 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 United States. 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?
Neoplastic polyp miss rate (time frame: 1 week). 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 28 Sep 2026.