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Cancer Screening Device

Gixam Device for Colorectal Cancer Screening

Phase 2
Recruiting
Research Sponsored by Jubaan Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects aged 45-85 years
Be older than 18 years old
Must not have
Family history of colorectal cancer, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age
History of colorectal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new device called Gixam that uses artificial intelligence to predict the presence of precancerous polyps in the colon or rectum by taking pictures of the tongue. The

Who is the study for?
This trial is for individuals who have tested negative on a Fecal Immunochemical Test (FIT) but still need to undergo colonoscopy screening for colorectal cancer. The study aims to include those who are due for standard care colonoscopy as part of their regular health check-up.
What is being tested?
The Gixam device, which uses images of the tongue and artificial intelligence to predict the presence of precancerous polyps in the colon or rectum, is being evaluated. Its accuracy will be compared with actual colonoscopy results.
What are the potential side effects?
Since Gixam involves taking pictures of the tongue and does not involve drugs or invasive procedures, there are no direct side effects from using this device itself. However, standard risks associated with bowel cleansing and colonoscopy apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 45 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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A close family member of mine had colorectal cancer.
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I have a history of colorectal cancer.
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I have been diagnosed with or have a history of inflammatory bowel disease.
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I cannot stick out my tongue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy - Gixam's sensitivity and specificity
Safety - number of device related adverse events and serious adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment3 Interventions
All participants will undergo the same study procedures: FIT, Gixam, and colonoscopy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colonoscopy after bowel cleansing
2013
Completed Phase 3
~320

Find a Location

Who is running the clinical trial?

Jubaan Ltd.Lead Sponsor
2 Previous Clinical Trials
1,600 Total Patients Enrolled
~267 spots leftby Mar 2025
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