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Tests treatment safety and results for CRC Screening
Official title Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
ClinicalTrials.gov ID: NCT07623902
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 84
You may be able to join if
- Participants aged ≥45 - ≤84 years.
- Able to provide a signed informed consent.
- Considered by a physician or healthcare provider as being of 'average risk' for CRC.
- Scheduled for a screening colonoscopy at investigation site.
You likely can't join if
- Undergoing colonoscopy for investigation of symptoms.
- Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have...
- Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.
- Has completed Cologuard, Sheild, ColoSense or Epi proColon testing within the preceding three (3) years.
- History of colorectal cancer.
- Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.
See the full eligibility criteria
- Participants aged ≥45 - ≤84 years.
- Able to provide a signed informed consent.
- Considered by a physician or healthcare provider as being of 'average risk' for CRC.
- Scheduled for a screening colonoscopy at investigation site.
- Undergoing colonoscopy for investigation of symptoms.
- Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
- Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.
- Has completed Cologuard, Sheild, ColoSense or Epi proColon testing within the preceding three (3) years.
- History of colorectal cancer.
- Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.
- Participant has a diagnosis or medical / family history of any of the following conditions, including:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
- Other hereditary cancer syndromes including but not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or...
- Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
- Participants with a disability to extend their tongue.
- Participants with tongue tremor.
- Participants with tongue piercing.
- Participants that had a dental visit in the 7 days prior to the Gixam test.
- Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.
- Participants that have taken anti-inflammatories or probiotics in the 14 days prior to the Gixam test.
- Participant is pregnant.
- Participant has any condition that in the opinion of the Investigator should preclude participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Northbrook, Illinois, United States
- Carmel, New York, United States
- Mentor, Ohio, United States
- Lynchburg, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Northbrook, Illinois, United States; Carmel, New York, United States; Mentor, Ohio, United States; Lynchburg, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.