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Computer-assisted detection device
Ultivision AI for Colon Polyps (RITUAL Trial)
N/A
Waitlist Available
Research Sponsored by Satisfai Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the procedure/surgery
Awards & highlights
RITUAL Trial Summary
This trial -tested device helps doctors identify colonic mucosal lesions during colonoscopies to catch potential medical issues.
Who is the study for?
This trial is for people aged 45 to 75 who are undergoing screening or surveillance colonoscopy. It's not suitable for those with inflammatory bowel disease, pregnant or lactating individuals, users of certain blood thinners that prevent polyp removal, anyone with colorectal cancer or positive fecal tests, and those with genetic polyposis syndromes or a history of significant colon surgery.Check my eligibility
What is being tested?
The trial is testing Ultivision AI, a tool designed to help doctors spot lesions like polyps in the colon during white light colonoscopy procedures. Participants will be randomly assigned to receive standard care with or without the assistance of this AI technology.See study design
What are the potential side effects?
Since Ultivision AI is a diagnostic aid used during colonoscopies and does not involve drugs or invasive treatments, it typically wouldn't have side effects like medications do. However, risks may include potential missed lesions if the device fails to identify them.
RITUAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the procedure/surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the procedure/surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adenoma Per Extraction (APE).
Adenoma per Colonoscopy (APC)
RITUAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ultivision AI colonoscopy (CADe Arm)Experimental Treatment1 Intervention
Ultivision AI is used to aid in real-time detection of adenomas.
Group II: Standard colonoscopy (Control Arm)Active Control1 Intervention
Patients will undergo standard colonoscopy without AI.
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Who is running the clinical trial?
Meditrial USA Inc.UNKNOWN
6 Previous Clinical Trials
1,678 Total Patients Enrolled
1 Trials studying Colon Adenomas
830 Patients Enrolled for Colon Adenomas
Satisfai Health, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called inflammatory bowel disease, which includes Crohn's disease or ulcerative colitis.You are taking medication that prevents the removal of polyps.You have colorectal cancer.You must agree to participate in the study after being informed about the details of the study.You have a genetic condition that causes multiple growths in your colon, such as Familial Adenomatous Polyposis, Cowden Syndrome, Lynch Syndrome, Peutz-Jeghers Syndrome, MUTYH Associated Polyposis, or Familial Colorectal Cancer Type X.You had surgery to remove part of your colon, but not your appendix.You recently had a procedure to examine your colon or are scheduled to have one soon.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Standard colonoscopy (Control Arm)
- Group 2: Ultivision AI colonoscopy (CADe Arm)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment criteria for this experiment limited to adults aged twenty and older?
"As per the trial's selection criteria, participants must be between 45 and 75 years of age."
Answered by AI
Is this experiment admitting any new participants currently?
"Information hosted on clinicaltrials.gov infers that this medical trial is temporarily not enrolling participants. The study first appeared online on April 3rd 2023 and was last edited on February 7th 2023, however there are currently 98 other studies actively seeking patients to participate in their research."
Answered by AI
Is my eligibility suitable for this medical experiment?
"This clinical trial, aimed at evaluating the effects of a new medical intervention on colon adenomas in adults between 45 and 75 years old, is presently enrolling 1100 participants. The primary eligibility criteria are as follows: Age range of 45 to 75; Undergone screening or surveillance endoscopy; Signed informed consent document."
Answered by AI
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