NCT06612281RecruitingPhase 2
Evaluation of Gixam's Performance in a FIT Negative Population
Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. The slow development of colorectal cancer makes it possible to detect and prevent it entirely by the removal of the precancerous polyps with colonoscopy. To date, there is no screening test, other than colonoscopy, able to detect the precancerous polyps. Gixam is a camera that takes multiple pictures of your tongue and uses artificial intelligence software to predict the presence of precancerous polyps within your colon or rectum that may eventually become cancerous. The device creates the prediction by comparing the images taken of your tongue with many other images of tongues from healthy patients and patients with a history of precancerous polyps. Patients who have been predicted by Gixam to have precancerous polyps may be more likely to complete colonoscopy at the interval recommended by their physician, potentially reducing the likelihood of developing colorectal cancer. The purpose of this research study is to test the accuracy of the Gixam device in persons that have received a negative outcome on a Fecal Immunochemical Test (FIT). This study will compare this prediction to the actual findings of your scheduled standard care colonoscopy and allow researchers to evaluate and improve the Gixam system.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 9 Sept 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 30 Mar 2025
- Lead sponsor
- Jubaan Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT06612281
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 400
- From 1 Nov 2024 to the primary completion date, 30 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Dental visit in the past 7 days prior to Gixam test.
Other illness
- History of colorectal cancer.
- Subject 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 are 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.
- Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn\'s disease.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Age
- Family history of colorectal cancer, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.
Other
- Undergoing diagnostic 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.
- Subjects with a disability to extend their tongue.
- Subjects with tongue piercing.
- Intake of pro-biotics over the past 3 months pre-Gixam test.
Who the study is looking for
- Subjects aged 45-85 years.
- Able to provide a signed informed consent.
- Scheduled for a screening colonoscopy at the investigation site.
Age in the registry: 45 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Oregon Clinic Gastroenterology-East Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.