Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer

NCT06688110 | Not Yet Recruiting

• 1 other identifier: CL-1004
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.

Conditions

Colorectal Cancer; Colorectal Adenomatous Polyp; Colorectal Neoplasms

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 premalignant neoplastic colorectal polyps (advanced premalignant neoplastic lesions/non-advanced premalignant neoplastic lesion) and CRC

  Through study completion, up to 30 days

Study Arms (1)

Gixam followed by standard of care colonoscopy

EXPERIMENTAL

All enrolled participants will undergo the Gixam test followed by a standard of care colonoscopy

Device: Gixam System

Interventions

Gixam System DEVICE

Jubaan's Gixam System is designed to predict the likelihood of colorectal adenomas or SSL by using white light in the 400 to 720 nm range to capture ultra-high-definition images of the of the tongue and analyzing the spectral signature of the oral microbiome to predict the presence of colorectal adenomas or SSL with help of artificial intelligence (AI).

Also known as: Colonoscopy

Gixam followed by standard of care colonoscopy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥50 - ≤80 years.
• Able to provide a signed informed consent.
• Underwent FIT screening within the past 6 months with a positive result.
• Scheduled for a FIT positive screening colonoscopy at investigational site.

You may not qualify if:

• Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention.
• Personal history of CRC.
• Family history of CRC, 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, and/or IBD-undefined.
• Subjects with the disability to extend their tongue.
• Subjects with tongue piercing.
• Dental visit in the 7 days prior to the 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
• Jubaan GmbH: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

Related Links

• Jubaan's website

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

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)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Daniella Bleistein

CONTACT

+972549599353; daniella@jubaan.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants and physician performing colonoscopy will be blinded to the Gixam outcome
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled subjects will undergo the Gixam test followed by a standard of care colonoscopy

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: February 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)