Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
Public ClinicalTrials.gov record NCT07623902. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to learn if the Gixam device effectively identifies persons with pre-cancer or cancer in the colon and rectum in adults aged 45-84 that are of average risk to develop colorectal cancer and have received a negative result on a Fecal Immunochemical Test (FIT). The main questions it aims to answer are: 1. Is the Gixam Device effective in identifying persons with pre-cancer or cancer in the colon and rectum that have received a negative FIT result? 2. Is the use of the Gixam device safe? Gixam test result will be compared to the findings of a standard of care screening colonoscopy. Study participants will: 1. Undergo the Gixam test 2. Take a FIT at home and ship to a laboratory. 3. Undergo a standard of care screening colonoscopy.
Study identification
- NCT ID
- NCT07623902
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,436 participants
Conditions and interventions
Conditions
Interventions
- Gixam System Device
- FIT Diagnostic Test
- Standard of care screening colonoscopy Procedure
Device · Diagnostic Test · Procedure
Eligibility (public fields only)
- Age range
- 45 Years to 84 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 17, 2026
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2026
- Last update posted
- Jun 2, 2026
2026
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orlando Gastroenterology, PA | Orlando | Florida | 32835 | Recruiting |
| Comprehensive Gastrointestinal Health, LLC | Northbrook | Illinois | 60062 | Recruiting |
| Westchester Putnam Gastro | Carmel | New York | 10549 | Recruiting |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | Recruiting |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07623902, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07623902 live on ClinicalTrials.gov.