Actively Recruiting
Evaluation of Gixam's Efficacy Predicting Advanced and Non-advanced Colorectal Neoplasia in Adults with Negative FIT Results
Led by Jubaan Ltd. · Updated on 2026-06-03
1436
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Gixam device to see if it can effectively identify adults aged 45 to 84 who have pre-cancer or cancer in the colon and rectum despite having a negative result on a Fecal Immunochemical Test (FIT). This study focuses on people considered at average risk for colorectal cancer and aims to assess both the device's accuracy and safety compared to standard screening methods. Participants in this study will undergo three procedures: the Gixam test, a FIT at home with stool sample mailing to a lab, and a standard screening colonoscopy which serves as the gold standard for comparison. All participants will receive the same interventions to ensure consistent evaluation of the Gixam system. During the study, participants will complete the Gixam test and FIT, followed by a screening colonoscopy. Researchers will monitor safety from enrollment through 30 days after the study ends and assess efficacy based on findings during this period. The main outcomes include the device's ability to detect colorectal neoplasia and its safety profile. Participation involves multiple visits and procedures over approximately one month.
CONDITIONS
Brief Title
Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 45 to 84 years
- Able to provide signed informed consent
- Considered average risk for colorectal cancer by a healthcare provider
- Scheduled for a screening colonoscopy at the study site
You will not qualify if you...
- Undergoing colonoscopy to investigate symptoms
- Colonoscopy within the previous 9 years, except a failed one due to poor bowel preparation within the last year without intervention
- Positive FIT or FOBT within the last 11 months
- Completed Cologuard, Shield, ColoSense, or Epi proColon testing within the last 3 years
- History of colorectal cancer
- Family history of colorectal cancer in a first-degree relative
- Diagnosis or family history of hereditary cancer syndromes such as FAP, HNPCC/Lynch Syndrome, Peutz-Jeghers, MAP, Turcot's, Cowden's, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis
- Diagnosis or personal history of inflammatory bowel disease including chronic ulcerative colitis or Crohn's disease
- Disability to extend the tongue
- Presence of tongue tremor
- Tongue piercing
- Dental visit within 7 days before the Gixam test
- Use of antibiotics or anti-fungal medications within 14 days before the Gixam test
- Use of anti-inflammatories or probiotics within 14 days before the Gixam test
- Pregnancy
- Any condition deemed by the investigator to preclude participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 30 days
Participants undergo the Gixam test, FIT stool sample collection at home, and a standard of care screening colonoscopy to evaluate colorectal neoplasia.
1 visit for Gixam test and colonoscopy; stool sample collected at home and mailed
Trial Site Locations
Total: 5 locations
1
Orlando Gastroenterology, PA
Orlando, Florida, United States, 32835
Actively Recruiting
2
Comprehensive Gastrointestinal Health, LLC
Northbrook, Illinois, United States, 60062
Actively Recruiting
3
Westchester Putnam Gastro
Carmel, New York, United States, 10549
Actively Recruiting
4
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
Actively Recruiting
5
Blue Ridge Medical Research
Lynchburg, Virginia, United States, 24502
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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