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

Обзор

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.

Вмешательства

• Устройство Gixam System
  All participant will undergo the Gixam test per device instructions for use
• Диагностический тест 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.
• Процедура Standard of care screening colonoscopy
  All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study

Первичные конечные точки

• Primary Safety Endpoint [Срок оценки: From enrollment to the end of study at 30 days after]
• Primary Efficacy Endpoints [Срок оценки: Through study completion, an average of 30 days]

Вторичные конечные точки (1)

• Confirmatory Secondary Efficacy Endpoints [Срок оценки: Through study completion, an average of 30 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 5 центров

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

Идентификаторы

NCT: NCT07623902 · CL-1009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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