Colon AdenomaRITUALNCT05732233
RITUAL Ultivision AI CADe Randomized Controlled Trial
A study testing Ultivision AI in people with Colon Adenoma and Polyp of Colon, run by Satisfai Health, Inc. at 4 sites in 3 countries.
Trial summary
Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas). Ultivision AI CADe is indicated for white light colonoscopy only. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colon Adenoma, Polyp of Colon, Adenoma Colon
- What is being tested?
- Ultivision AI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Jul 2023to 23 Feb 2024
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 75 years;
- Screening or surveillance colonoscopy.
- Iinformed consent
Who cannot join
- Colorectal cancer;
- Inflammatory bowel disease, including Crohn's disease or ulcerative colitis;
- Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X;
- Positive Fecal Immunochemical Test;
- Use anti-platelet agents or anticoagulants that prevent polyps removal;
- Colon resection, not including the appendix;
- Subject is pregnant or lactating.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
UC Irvine
Irvine, California, 92697
University of Kansas Medical Center
Kansas City, Kansas, 66160
Canada1 site
University of Montreal Research Center (CRCHUM)
Montréal (Québec), Montreal, H2X 0A9
About this study
Official title: Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy
Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas).
Ultivision AI CADe is indicated for white light colonoscopy only.
Read the detailed description
Ultivision AI contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (CNN).
The algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.
- Conditions
- Colon Adenoma, Polyp of Colon, Adenoma Colon
- Being tested
- Ultivision AI
- Keywords
- Screening, Surveillance, Artificial Intelligence, Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultivision AIDevice
Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas) in adult patients undergoing colorectal cancer screening and surveillance examinations.
| Study group | Role | What they receive |
|---|---|---|
| Ultivision AI colonoscopy (CADe Arm) | Experimental | Ultivision AI is used to aid in real-time detection of adenomas. Receives: Device: Ultivision AI |
| Standard colonoscopy (Control Arm) | Active comparator | Patients will undergo standard colonoscopy without AI. Receives: Device: Ultivision AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma per Colonoscopy (APC)
Superiority of Ultivision-AI arm versus control arm. APC is defined as the total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Measured: During the procedure/surgery
Adenoma Per Extraction (APE).
Non inferiority of Ultivision-AI arm versus control arm. Where APE is the fraction of adenoma, sessile serrated lesions, and large (>10mm) hyperplastic polyps of the proximal colon (caecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections.
Measured: During the procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start21 Jul 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Why it stopped: Business decision to discontinue the study. Discontinuation is not related to any patient safety or performance issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon AdenomaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel trial design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satisfai Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial USA Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732233
- Sponsor's protocol ID
- STF-2023-01
- Acronym
- RITUAL
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.
PubMed 29928897
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy
- ClinicalTrials.gov ID
- NCT05732233
- Acronym / sponsor ID
- RITUAL / STF-2023-01
- Conditions
- Colon Adenoma, Polyp of Colon, Adenoma Colon
- Keywords
- Screening, Surveillance, Artificial Intelligence, Colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to discontinue the study. Discontinuation is not related to any patient safety or performance issues.
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Satisfai Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Meditrial USA Inc.
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 16 Feb 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.
Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas).
Ultivision AI CADe is indicated for white light colonoscopy only.
Detailed description
Ultivision AI contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (CNN).
The algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel trial design
| Arm | Type | Receives |
|---|---|---|
| Ultivision AI colonoscopy (CADe Arm) | Experimental | Device: Ultivision AIUltivision AI is used to aid in real-time detection of adenomas. |
| Standard colonoscopy (Control Arm) | Active comparator | Device: Ultivision AIPatients will undergo standard colonoscopy without AI. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 45 to 75 years;
- Screening or surveillance colonoscopy.
- Iinformed consent
Key exclusion criteria (7 listed)
- Colorectal cancer;
- Inflammatory bowel disease, including Crohn's disease or ulcerative colitis;
- Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X;
- Positive Fecal Immunochemical Test;
- Use anti-platelet agents or anticoagulants that prevent polyps removal;
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 |
|---|---|---|
| Ultivision AIUltivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas) in adult patients undergoing colorectal cancer screening and surveillance examinations. | Device | Standard colonoscopy (Control Arm), Ultivision AI colonoscopy (CADe Arm) |
Primary outcome
Adenoma per Colonoscopy (APC)
Time frame: During the procedure/surgery
Superiority of Ultivision-AI arm versus control arm. APC is defined as the total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Adenoma Per Extraction (APE).
Time frame: During the procedure/surgery
Non inferiority of Ultivision-AI arm versus control arm. Where APE is the fraction of adenoma, sessile serrated lesions, and large (>10mm) hyperplastic polyps of the proximal colon (caecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections.
Results and safety
The study was stopped early (reason given: Business decision to discontinue the study. Discontinuation is not related to any patient safety or performance issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Results publication: PubMed 29928897Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.
- Satisfai HealthLink provided by the sponsor.
- Meditrial Clinical Research OrganizationLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultivision AI in people with Colon Adenoma and Polyp of Colon, run by Satisfai Health, Inc. at 4 sites in 3 countries.
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 7 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: stopped early, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, Italy. 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 was stopped early (reason given: Business decision to discontinue the study. Discontinuation is not related to any patient safety or performance issues.). Results are not available in the source record.
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 per Colonoscopy (APC) (time frame: During the procedure/surgery). 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?
On the ClinicalTrials.gov record for NCT05732233, which also lists 1 linked publication.
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 13 May 2024.