NCT07623902招募中不适用
Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
干预措施
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
- 9
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.
- •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.
研究组 & 干预措施
Intervention arm
Experimental
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
Experimental
All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy
干预措施: Gixam System (Device)
Intervention arm
Experimental
All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy
干预措施: FIT (Diagnostic Test)
研究者
研究点 (9)
Loading locations...
相似试验
Enrolling By Invitation
2 期
Gemcitabine and Nab-Paclitaxel Combined With Iparomlimab and Tuvorilimab for Advanced Gallbladder CancerNCT07310069Xinhua Hospital, Shanghai Jiao Tong University School of Medicine44
尚未招募
不适用
Understanding the Clinical Benefits of Gliclazide in Type 2 Diabetes: An Indian KAP StudyCTRI/2026/04/107639Dr. Reddys Laboratories Ltd.250
尚未招募
Unknown
A study to see if the Density Device helps improve loose skin in people losing weight with GLP-1/GIP medicines.CTRI/2025/10/096688Jeisys Medical Inc.18
尚未招募
2/3 期
A study of two Ayurvedic heat treatments to improve pain and shoulder movement in Frozen shoulder.CTRI/2026/01/102465Dr Dayasagar Balajirao Jadhav60
已完成
1 期
This is clinical study to test, for the first time in people, the safety (any
good or bad effects), how long the drug can stay in the body and if it can
control the disease of people diagnosed with advanced cancer that has not
responded to treatment, has returned after it has been treated, or cannot
be treated by surgery, drugs, or any other known treatments.2023-509969-20-00Celgene Corp.127