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Recruiting NCT07623902

Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population

No phase Interventional CRC Screening Microbiome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gixam System, FIT, Standard of care screening colonoscopy.
Who it may be relevant to
Registry conditions: CRC Screening, Microbiome. Basic parameters: 45 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Gixam System
    All participant will undergo the Gixam test per device instructions for use
  • Diagnostic test FIT
    FIT kit will be handed out to the study participant, who will later sample stool at home and mail the specimen to a reference laboratory for analysis.
  • Procedure Standard of care screening colonoscopy
    All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study

Primary outcome measures

  • Primary Safety Endpoint [Time frame: From enrollment to the end of study at 30 days after]
  • Primary Efficacy Endpoints [Time frame: Through study completion, an average of 30 days]
Secondary outcome measures (1)
  • Confirmatory Secondary Efficacy Endpoints [Time frame: Through study completion, an average of 30 days]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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 Familial Hyperplastic Polyposis.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 5 centers
  • Orlando Gastroenterology, PA — Orlando
  • Comprehensive Gastrointestinal Health, LLC — Northbrook
  • Westchester Putnam Gastro — Carmel
  • Great Lakes Gastroenterology Research, LLC — Mentor
  • Blue Ridge Medical Research — Lynchburg

Identifiers

NCT: NCT07623902 · CL-1009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗