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

NCT ID: NCT06688110

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-04-30

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.

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.

Conditions

Colorectal Cancer; Colorectal Adenomatous Polyp; Colorectal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Gixam followed by standard of care colonoscopy

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

Group Type: EXPERIMENTAL

Gixam System

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Colonoscopy

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jubaan GmbH

UNKNOWN

Sponsor Role: collaborator

Jubaan Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Erasmus MC

Rotterdam, , Netherlands

Countries

Netherlands

Central Contacts

Daniella Bleistein

Role: CONTACT

daniella@jubaan.com

+972549599353

Facility Contacts

Michiel Maas, MD

Role: primary

Related Links

https://jubaan.com/

Jubaan's website

Other Identifiers

CL-1004

Identifier Type: -

Identifier Source: org_study_id