Evaluation of Gixam's Performance in a FIT Negative Population

NCT06612281 | Recruiting Phase 2 FDA Device

• 1 other identifier: CL-1015
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. The slow development of colorectal cancer makes it possible to detect and prevent it entirely by the removal of the precancerous polyps with colonoscopy. To date, there is no screening test, other than colonoscopy, able to detect the precancerous polyps. Gixam is a camera that takes multiple pictures of your tongue and uses artificial intelligence software to predict the presence of precancerous polyps within your colon or rectum that may eventually become cancerous. The device creates the prediction by comparing the images taken of your tongue with many other images of tongues from healthy patients and patients with a history of precancerous polyps. Patients who have been predicted by Gixam to have precancerous polyps may be more likely to complete colonoscopy at the interval recommended by their physician, potentially reducing the likelihood of developing colorectal cancer. The purpose of this research study is to test the accuracy of the Gixam device in persons that have received a negative outcome on a Fecal Immunochemical Test (FIT). This study will compare this prediction to the actual findings of your scheduled standard care colonoscopy and allow researchers to evaluate and improve the Gixam system.

Conditions

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

Keywords

Microbiome; Spectral signature; Artificial intelligence

Outcome Measures

Primary Outcomes (2)

• Safety - number of device related adverse events and serious adverse events

  Number of device related adverse events and serious adverse events

  Through study completion, up to 30 days

• Efficacy - Gixam's sensitivity and specificity

  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.

  Through study completion, up to 30 days

Study Arms (1)

Single arm

EXPERIMENTAL

All participants will undergo the same study procedures: FIT, Gixam, and colonoscopy

Device: colorectal cancer (CRC) screening; Diagnostic Test: colorectal cancer screening; Procedure: Colonoscopy after bowel cleansing

Interventions

colorectal cancer (CRC) screening DEVICE

Gixam test

Single arm

colorectal cancer screening DIAGNOSTIC_TEST

Fecal Immunochemistry Test (FIT)

Single arm

Colonoscopy after bowel cleansing PROCEDURE

Standard of care optical colonoscopy for colorectal cancer screening

Single arm

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 45-85 years.
• Able to provide a signed informed consent.
• Scheduled for a screening colonoscopy at the investigation site.

You may not qualify if:

• Undergoing diagnostic colonoscopy for investigation of symptoms.
• Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
• History of colorectal cancer.
• Family history of colorectal cancer, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.
• Subject has a diagnosis or medical / family history of any of the following conditions, including:
• 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.
• Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn\'s disease.
• Subjects with a disability to extend their tongue.
• Subjects with tongue piercing.
• Dental visit in the past 7 days prior to Gixam test.
• Intake of pro-biotics over the past 3 months pre-Gixam test.
• Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Sponsors & Collaborators

• Jubaan Ltd.: lead

Study Sites (1)

The Oregon Clinic Gastroenterology-East

Portland, Oregon, 97220, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Central Study Contacts

Daniella Bleistein

CONTACT

+972549599353; daniella@jubaan.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Participant and physician performing colonoscopy will be masked to FIT and Gixam test outcome until colonoscopy procedure us completed.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects enrolled will undergo the same study procedures and assessments in the following order: FIT, Gixam, and colonoscopy. Gixam is an investigational medical device determined by the FDA to be a nonsignificant risk device. Colonoscopy is the ground-truth (Gixam outcome is compared to colonoscopy findings). Gixam performance will be evaluated and reported per FIT outcome (the primary efficacy endpoint is sensitivity and specificity in a FIT negative population).

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 25, 2024
• Study Start: November 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)