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
Qualifiers
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
Treatments tested in this trial
- Gixam System
Treatment groups
800 Participants
are divided into 1 treatment groupSponsors and collaborators
Jubaan Ltd.
Lead sponsor
Jubaan GmbH
Collaborator
Source ClinicalTrials.gov