Evaluation of Gixam's Repeatability and Reproducibility Predicting the Presence of Advanced and Non-Advanced Colorectal Neoplasia

Summary

The goal of this clinical trial is to learn if the Gixam tongue-imaging test gives the same result each time it is done, in adults aged 45 to 84 who are at average risk for colorectal cancer and are scheduled for a screening colonoscopy. The main questions it aims to answer are: * Does Gixam give the same result when the test is repeated on the same day, with the same device and the same staff member (repeatability)? * Does Gixam give the same result when the test is done on different days, with different devices and different staff members (reproducibility)? Participants will: * Answer questions about their health, medicines, diet, alcohol and tobacco use, and oral care habits * Have the Gixam tongue test 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14 * On Days 7 and 14, report when they last ate, drank or smoked, and whether they brushed, scraped their tongue or used mouthwash * Then join the main Gixam study (CL-1009) for a FIT stool test and their planned colonoscopy

Eligibility

Age range

45–84 years

Sex

All

Healthy volunteers

No

Interventions

• Device
  Gixam System

  Repeated Gixam tests, 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14

Location