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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colorectal Adenomatous Polyp
• Intervention / Treatment: Device: Gixam System

Detailed Description

1. Average risk persons eligible for CRC screening that have received a positive FIT outcome in the past 6 months and are scheduled for a screening colonoscopy at one of the participating centers will be offered to participate in the study.

2. Following the informed consent process, subjects will undergo the Gixam test.

   1. A subset of 50 subjects will participate in the repeatability assessment. They will undergo three (3) repetitive Gixam tests one after the other, by the same operator.
   2. Both the subject and the endoscopist will be blinded to the Gixam outcome
3. All subjects will thereafter undergo a standard of care HD-WL colonoscopy procedure.
4. All resected and retrieved lesions will be sent separately for histopathological evaluation.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniella Bleistein; Phone Number: +972549599353; Email: daniella@jubaan.com

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus MC
    • Contact: Michiel Maas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Personal history of CRC.
3. Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.

4. 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.
5. 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.
6. Subjects with the disability to extend their tongue.
7. Subjects with tongue piercing.
8. Dental visit in the 7 days prior to the Gixam test.
9. Intake of pro-biotics over the past 3 months pre-Gixam test.
10. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: Gixam System; 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).; Other Names: Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jubaan Ltd.
• Collaborators: Jubaan GmbH

Publications and helpful links

Helpful Links

• Jubaan's website

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Estimated): November 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Colonic Diseases; Adenoma; Colorectal Neoplasms; Polyps; Adenomatous Polyps
• Other Study ID Numbers: CL-1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No