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

2026年10月18日 更新者：Jubaan Ltd.

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1436

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Dothan、Alabama、美国、36301
      • Mobile、Alabama、美国、36606
        • 招聘中
        • East View Medical Research, LLC
        • 接触：
    • California
      • Lancaster、California、美国、93534
        • 招聘中
        • Gastro Care Institute
        • 接触：
    • Florida
    • Illinois
      • Northbrook、Illinois、美国、60062
        • 主动，不招人
        • Comprehensive Gastrointestinal Health, LLC
    • New York
      • Carmel、New York、美国、10549
        • 招聘中
        • Westchester Putnam Gastro
        • 接触：
      • New York、New York、美国、10016
    • Ohio
      • Mentor、Ohio、美国、44060
        • 招聘中
        • Great Lakes Gastroenterology Research, LLC
        • 接触：
    • Virginia
      • Lynchburg、Virginia、美国、24502

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年 至 84年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Participants aged ≥45 - ≤84 years.
  2. Able to provide a signed informed consent.
  3. Considered by a physician or healthcare provider as being of 'average risk' for CRC.
  4. Scheduled for a screening colonoscopy at investigation site.

Exclusion Criteria:

  1. Undergoing colonoscopy for investigation of symptoms.

  2. 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.

  3. Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.

  4. Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years.

  5. History of colorectal cancer.

  6. Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.

  7. 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.

  8. Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.

  9. Participants with a disability to extend their tongue.

  10. Participants with tongue tremor.

  11. Participants with tongue piercing.

  12. Participants that had a dental visit in the 7 days prior to the Gixam test.

  13. Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.

  14. Participants that have taken probiotics in the 14 days prior to the Gixam test.

  15. Participant is pregnant.

  16. Participant has any condition that in the opinion of the Investigator should preclude participation in the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：放映
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention arm

All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy
设备：Gixam System

All participant will undergo the Gixam test per device instructions for use

诊断测试：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.

程序：Standard of care screening colonoscopy

All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Primary Safety Endpoint
大体时间：From enrollment to the end of study at 30 days after

Number of device-related adverse events and serious adverse events.
From enrollment to the end of study at 30 days after
Primary Efficacy Endpoints
大体时间：Through study completion, an average of 30 days

Sensitivity and specificity of Gixam in participants with a negative FIT result.
Through study completion, an average of 30 days

次要结果测量

结果测量
措施说明
大体时间
Confirmatory Secondary Efficacy Endpoints
大体时间：Through study completion, an average of 30 days

Standalone sensitivity and specificity of Gixam in general average risk population.
Through study completion, an average of 30 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jubaan Ltd.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月18日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年10月20日

上次提交的符合 QC 标准的更新

2026年10月18日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • CL-1009

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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