Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorJubaan Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
Trial design
Design model
Sequential
Treatments tested in this trial
Gixam System
DeviceJubaan'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).
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Gixam followed by standard of care colonoscopyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 days2
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jubaan Ltd.
Lead sponsor
Jubaan GmbH
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: