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Artificial Intelligence

Gixam followed by standard of care colonoscopy for Gastrointestinal Microbiome

N/A
Recruiting
Research Sponsored by Jubaan Ltd.
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 14 days (till pathology report is received)
Awards & highlights

Study Summary

"This trial will test the accuracy of the Gixam™ System in identifying colorectal adenomas compared to traditional colonoscopy. Subjects will have images of their tongue taken with the Gixam™

Who is the study for?
This trial is for individuals scheduled for a routine colonoscopy. They will be asked to participate by having images of their tongue taken with the Gixam™ System, which uses AI to predict the presence of adenomatous polyps in the colon.Check my eligibility
What is being tested?
The Gixam™ System's ability to predict colorectal adenomas is being tested. Participants' tongues are imaged and analyzed by AI before they undergo their standard colonoscopy, and results from both methods are compared.See study design
What are the potential side effects?
Since this study involves taking images of the tongue and does not involve drugs or invasive procedures, there are no direct side effects associated with the Gixam™ System itself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days (till pathology report is received)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days (till pathology report is received) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Endpoint - Gixam's diagnostic accuracy
Primary Safety Endpoint - Number of device related adverse events and serious adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gixam followed by standard of care colonoscopyExperimental Treatment1 Intervention
This is a single-arm study. All participants will undergo the Gixam test following a standard of care colonoscopy

Find a Location

Who is running the clinical trial?

Jubaan Ltd.Lead Sponsor
Daniella BleisteinStudy DirectorJubaan Ltd.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study accept participants who are aged 60 and above?

"Eligible participants must be between 45 and 75 years old to enroll in this study."

Answered by AI

What is the current number of participants under observation in this clinical investigation?

"Indeed, information from clinicaltrials.gov confirms the ongoing recruitment of participants for this investigation. The trial was initially listed on August 1st, 2023 and last revised on March 10th, 2024. Enrollment aims to include a total of 800 patients distributed between two specified sites."

Answered by AI

Are new participants currently being sought for this medical study?

"As per clinicaltrials.gov, this current trial is actively seeking candidates. The initial posting date for the study was 8/1/2023 with the most recent update made on 3/10/2024."

Answered by AI
~350 spots leftby Dec 2024