Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Jubaan Ltd.
- 入组人数
- 1,436
- 试验地点
- 8
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
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:
- 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?
- 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:
- Undergo the Gixam test
- Take a FIT at home and ship to a laboratory.
- Undergo a standard of care screening colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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 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.
研究组 & 干预措施
Intervention arm
All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy
干预措施: Standard of care screening colonoscopy (Procedure)
Intervention arm
All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy
干预措施: Gixam System (Device)
Intervention arm
All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy
干预措施: FIT (Diagnostic Test)
结局指标
主要结局
Primary Safety Endpoint
时间窗: From enrollment to the end of study at 30 days after
Number of device-related adverse events and serious adverse events.
Primary Efficacy Endpoints
时间窗: Through study completion, an average of 30 days
Sensitivity and specificity of Gixam in participants with a negative FIT result.
次要结局
- Confirmatory Secondary Efficacy Endpoints(Through study completion, an average of 30 days)