NCT07623902Toboroz
Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 20.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1436 (tervezett)
- Első benyújtás
- 2026. máj. 21.
- Kezdés
- 2026. máj. 18.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- Jubaan Ltd.
- NCT-szám
- NCT07623902
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 1436
- 2026. máj. 18. és az elsődleges befejezés (2026. dec. 31.) között
- 9 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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 probiotics in the 14 days prior to the Gixam test.
Más betegség
- History of colorectal cancer.
- 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.
- Participant has any condition that in the opinion of the Investigator should preclude participation in the study.
Életkor
- Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.
Egyéb
- 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.
- Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years.
- Participants with a disability to extend their tongue.
- Participants with tongue tremor.
- Participants with tongue piercing.
- Participant is pregnant.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 45 év – 84 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (9)
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Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.