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Evaluating Gixam for Colorectal Cancer Screening

This study is evaluating a new device called Gixam for colorectal cancer (CRC) screening. Gixam is a camera that takes pictures of your tongue and uses artificial intelligence to predict if you have precancerous polyps in your colon or rectum. These polyps can eventually turn into cancer. The study aims to see how well Gixam works (its sensitivity and specificity) and if it is safe. You might be able to join if you are between 45 and 85 years old, are scheduled for a screening colonoscopy (a procedure to look inside your colon), and have had a negative Fecal Immunochemistry Test (FIT), which checks for blood in your stool. The study is currently unclear on its recruitment status and plans to enroll about 400 people.

Study design
This interventional study plans to enroll about 400 participants. It is evaluating the Gixam test and a standard colonoscopy for colorectal cancer screening.
What's involved
You would undergo the Gixam test, a Fecal Immunochemistry Test (FIT), and a colonoscopy after bowel cleansing. The study will measure safety and effectiveness through study completion, up to 30 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, up to 30 days, to measure safety and efficacy.

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NCT06612281

Evaluation of Gixam's Performance in a FIT Negative Population

Recruiting
PHASE2Ages 45–85InterventionalScreening
Jubaan Ltd.
~400 participants
Updated 2024-11-14 on ClinicalTrials.gov
What's tested:colorectal cancer (CRC) screeningcolorectal cancer screeningColonoscopy after bowel cleansing

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety - number of device related adverse events and serious adverse events
Measured over Through study completion, up to 30 days
+1 more outcome measured

Conditions

Colorectal Adenoma
Colorectal Cancer (CRC)
Colorectal Cancer (CRC) Screening

Explore related trials

Colorectal AdenomaColorectal Carcinoma

Where it's being run

1 sites across 1 states
Oregon1

Who to contact

Daniella Bleistein
[email protected]
+972549599353
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Familial adenomatous polyposis (also referred to as \"FAP\", including attenuated FAP and Gardner\'s syndrome),
Hereditary non-polyposis CRC syndrome (also referred to as \"HNPCC\" or \"Lynch Syndrome\"),
Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot\'s (or Crail\'s) Syndrome, Cowden\'s Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis. 6. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn\'s disease. 7. Subjects with a disability to extend their tongue. 8. Subjects with tongue piercing. 9. Dental visit in the past 7 days prior to Gixam test. 10. Intake of pro-biotics over the past 3 months pre-Gixam test. 11. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

What this trial measures

  • Safety - number of device related adverse events and serious adverse eventsThrough study completion, up to 30 days

    Number of device related adverse events and serious adverse events

  • Efficacy - Gixam's sensitivity and specificityThrough study completion, up to 30 days

    Gixam's sensitivity and specificity to predict the presence of colorectal adenoma or sessile serrated lesions (advances and non-advanced) / CRC in a FIT negative population.