NCT06688110

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Jubaan Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2024-11-14
• Last updated: 2024-11-14

Locations

1 site across 1 country: Netherlands