AI-assisted ColonoscopyNCT07661914
AI_Colonoscopy_for_Fellows
A study testing AI assisted colonoscopy and Conventional Colonoscopy in people with AI-assisted Colonoscopy, run by University of Oklahoma at 1 site in United States.
Trial summary
The goal of this study is to look at how good artificial intelligence (AI) assisted colonoscopy is compared to conventional colonoscopy in detecting polyps when used by gastroenterology fellows. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- AI-assisted Colonoscopy
- What is being tested?
- AI assisted colonoscopy and Conventional Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Jul 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All adult gastroenterology fellows at the University of Oklahoma, except for the fellow conducting research will be included in the study.
Who cannot join
- All patients undergoing colonoscopy for genetic cancer syndromes (ex: polyposis), inflammatory bowel disease, for therapy of known neoplasms or undergoing non-colonoscopy screening tests (fecal immunochemical test, CT colonography) will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma City VA Health Care System
Oklahoma City, Oklahoma, 73104
About this study
Official title: Efficacy of Artificial Intelligence Assisted Colonoscopy in Improving Adenoma Detection Rates for Gastroenterology Fellows
The goal of this study is to look at how good artificial intelligence (AI) assisted colonoscopy is compared to conventional colonoscopy in detecting polyps when used by gastroenterology fellows. The main question the study aims to answer are:
Does AI assisted colonoscopy improve adenoma detection rate for gastroenterology fellows in different levels of training? Does AI assisted colonoscopy improve other quality indicators such as sessile serrated lesion detection rate withdrawal time? This research will compare these quality measures for gastroenterology fellows in their first, second, and third year of training. The gastroenterology fellows performing colonoscopies will be randomized to either AI assisted colonoscopy or conventional colonoscopy for each case. The nurse in the room will then turn on the AI device if needed and the rest of the colonoscopy will be completed as normal. The procedure notes will indicated whether AI device was used or not during the procedure.
Read the detailed description
The proposed study is a randomized controlled trial to evaluate the efficacy of AI assisted colonoscopies in improving colonoscopy quality indices for gastroenterology fellows.
The subjects for this study will be the gastroenterology fellows in their first, second or third year of training. Each fellow during their VA endoscopy rotation will be randomized to perform colonoscopies using AI or following conventional methods. If randomized to AI, the endoscopy technician in the procedural room will be responsible for turning on the GI Genius software (Medtronic AI device) during the procedure. The fellow will identify whether AI was used in the procedural note documented under Provation MD software. Otherwise, all colonoscopies will be performed in the standard fashion under moderate sedation or monitored anesthesia care. Procedures will not be affected by study participation. All procedures will be performed at the Oklahoma City VA Medical Center during normal procedural times. Information such as indication for the procedure and quality indices mentioned above (such as ADR, SSLDR, withdrawal time) will be obtained from chart review and calculated using data from Provation MD retrospectively, at a later time. Other information such as patient's medical history and family history as it relates to the colonoscopy procedure will also be collected retrospectively from CPRS chart records. This will be used to exclude patients undergoing colonoscopy secondary to genetic cancer syndromes (ex: polyposis), inflammatory bowel disease, for therapy of known neoplasms or undergoing non-colonoscopy screening tests (fecal immunochemical test, CT colonography) from this study. No identifiable patient information will be saved in any format. In addition, data such as polyp size, location of polyp and histological information will be collected from CPRS charts.
- Conditions
- AI-assisted Colonoscopy
- Being tested
- AI assisted colonoscopy, Conventional Colonoscopy
- Keywords
- AI assisted colonoscopy, GI Genius
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI assisted colonoscopyDevice
The gastroenterology fellows assigned to AI assisted colonoscopy will use the GI genius device while performing colonoscopies.
Conventional ColonoscopyOther
The gastroenterology fellows assigned to conventional colonoscopy will be performing colonoscopies without the use of AI device.
| Study group | Role | What they receive |
|---|---|---|
| AI assisted colonoscopy | Experimental | GI fellows in this arm will complete colonoscopies with the assistance of AI device GI Genius. Receives: Device: AI assisted colonoscopy |
| Conventional colonoscopy | Active comparator | GI fellows in this arm will complete colonoscopy in a conventional manner Receives: Other: Conventional Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
We hypothesize that an AI assisted colonoscopy done by a gastroenterology fellow will have a higher ADR as compared to conventional colonoscopy done by the same fellow and these results will be more significant among junior fellows compared to senior fellows.
Measured: over 18 months
Secondary outcomes (2)
Sessile serrated lesion detection rate
We hypothesize that an AI assisted colonoscopy done by a gastroenterology fellow will have a higher sessile serrated lesion detection rate as compared to conventional colonoscopy done by the same fellow and these results will be more significant among junior fellows compared to senior fellow.
Measured: Over 18 months
Withdrawal time
Total withdrawal time will likely be longer in the AI assisted colonoscopy group compared to conventional colonoscopy group.
Measured: Over 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Apr 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI-assisted 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- In this study each gastroenterology fellow will be randomized to either AI assisted colonoscopy arm vs conventional colonoscopy for each case. Thus each fellow will function as his or her own control.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma City VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Mohammad Madhoun, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661914
- Sponsor's protocol ID
- 18531
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artificial Intelligence Assisted Colonoscopy in Improving Adenoma Detection Rates for Gastroenterology Fellows
- ClinicalTrials.gov ID
- NCT07661914
- Acronym / sponsor ID
- 18531
- Conditions
- AI-assisted Colonoscopy
- Keywords
- AI assisted colonoscopy, GI Genius
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma City VA Medical Center
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Jun 2026 (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 study is to look at how good artificial intelligence (AI) assisted colonoscopy is compared to conventional colonoscopy in detecting polyps when used by gastroenterology fellows. The main question the study aims to answer are:
Does AI assisted colonoscopy improve adenoma detection rate for gastroenterology fellows in different levels of training? Does AI assisted colonoscopy improve other quality indicators such as sessile serrated lesion detection rate withdrawal time? This research will compare these quality measures for gastroenterology fellows in their first, second, and third year of training. The gastroenterology fellows performing colonoscopies will be randomized to either AI assisted colonoscopy or conventional colonoscopy for each case. The nurse in the room will then turn on the AI device if needed and the rest of the colonoscopy will be completed as normal. The procedure notes will indicated whether AI device was used or not during the procedure.
Detailed description
The proposed study is a randomized controlled trial to evaluate the efficacy of AI assisted colonoscopies in improving colonoscopy quality indices for gastroenterology fellows.
The subjects for this study will be the gastroenterology fellows in their first, second or third year of training. Each fellow during their VA endoscopy rotation will be randomized to perform colonoscopies using AI or following conventional methods. If randomized to AI, the endoscopy technician in the procedural room will be responsible for turning on the GI Genius software (Medtronic AI device) during the procedure. The fellow will identify whether AI was used in the procedural note documented under Provation MD software. Otherwise, all colonoscopies will be performed in the standard fashion under moderate sedation or monitored anesthesia care. Procedures will not be affected by study participation. All procedures will be performed at the Oklahoma City VA Medical Center during normal procedural times. Information such as indication for the procedure and quality indices mentioned above (such as ADR, SSLDR, withdrawal time) will be obtained from chart review and calculated using data from Provation MD retrospectively, at a later time. Other information such as patient's medical history and family history as it relates to the colonoscopy procedure will also be collected retrospectively from CPRS chart records. This will be used to exclude patients undergoing colonoscopy secondary to genetic cancer syndromes (ex: polyposis), inflammatory bowel disease, for therapy of known neoplasms or undergoing non-colonoscopy screening tests (fecal immunochemical test, CT colonography) from this study. No identifiable patient information will be saved in any format. In addition, data such as polyp size, location of polyp and histological information will be collected from CPRS charts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study each gastroenterology fellow will be randomized to either AI assisted colonoscopy arm vs conventional colonoscopy for each case. Thus each fellow will function as his or her own control.
| Arm | Type | Receives |
|---|---|---|
| AI assisted colonoscopy | Experimental | Device: AI assisted colonoscopyGI fellows in this arm will complete colonoscopies with the assistance of AI device GI Genius. |
| Conventional colonoscopy | Active comparator | Other: Conventional ColonoscopyGI fellows in this arm will complete colonoscopy in a conventional manner |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adult gastroenterology fellows at the University of Oklahoma, except for the fellow conducting research will be included in the study.
Key exclusion criteria (1 listed)
- All patients undergoing colonoscopy for genetic cancer syndromes (ex: polyposis), inflammatory bowel disease, for therapy of known neoplasms or undergoing non-colonoscopy screening tests (fecal immunochemical test, CT colonography) will be excluded from this study.
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 |
|---|---|---|
| AI assisted colonoscopyThe gastroenterology fellows assigned to AI assisted colonoscopy will use the GI genius device while performing colonoscopies. | Device | AI assisted colonoscopy |
| Conventional ColonoscopyThe gastroenterology fellows assigned to conventional colonoscopy will be performing colonoscopies without the use of AI device. | Other | Conventional colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: over 18 months
We hypothesize that an AI assisted colonoscopy done by a gastroenterology fellow will have a higher ADR as compared to conventional colonoscopy done by the same fellow and these results will be more significant among junior fellows compared to senior fellows.
2 secondary outcomes
Sessile serrated lesion detection rate
Time frame: Over 18 months
Withdrawal time
Time frame: Over 18 months
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 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mohammad Madhoun principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI assisted colonoscopy and Conventional Colonoscopy in people with AI-assisted Colonoscopy, run by University of Oklahoma 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 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 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?
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?
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?
Adenoma detection rate (time frame: over 18 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 22 Jun 2026.