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.
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
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
800
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).
Erasmus MC
Rotterdam, Netherlands
Safety - number of device related adverse events and serious adverse events
Number of device related adverse events and serious adverse events
Time frame: 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
Time frame: Through study completion, up to 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.