Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03356002
Eligibility Criteria:
Inclusion Criteria
* Male or female at the age of 40-80 years old
* Subject provided signed informed consent
Subjects to be enrolled in this study are indicated and scheduled to undergo optical colonoscopy based on the following symptoms or by being classified as higher than average risk based on one or more of the following:
Surveillance - Significant findings in previous optical colonoscopy Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy Diagnostic - Polyps detected in previous optical colonoscopy (community setting) referred for polypectomy Diagnostic - Positive FIT test
Diagnostic - one or more of the typical symptoms:
abdominal pain Change in bowel habits Anemia or overt bleeding in stool Significant weight loss
1st degree relatives of CRC subjects Alternatively average risk based on their age and demographics referred for screening for polyps.
Exclusion Criteria:
* Subjects with advanced cancer or other life threatening diseases or conditions
* Subject with known history of dysphagia or other swallowing disorders
* Subject with known history of GI disease or symptoms, such as: Crohn's disease, Colitis, Inflammatory Bowel Disease \[IBD\], Meckel's Diverticulum, Bowen Hernia, Mega Colon, fistulas or other strictures (doctors' discretion).
* Subject with known motility disorder or Chronic Constipation (less than 3 bowel movements/week)
* Subject with known delayed gastric emptying
* Subject with prior history of abdominal surgery that might cause bowel strictures leading to capsule retention, as determined by physician discretion
* Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy, as determined by physician discretion
* Subject with a cardiac pacemaker or other implanted electro medical device
* Subjects with known sensitivity to iodine, or with kidney failure
* Subjects with morbid obesity (BMI \> 40)
* Subjects with belly / girth circumference \> 125 cm
* Subject with any known condition which precludes compliance with study and/or device instructions
* Subject with known condition of drug abuse and/or alcoholism
* Subject who is unable to undergo colonoscopy or bowel preparation necessary for colonoscopy (based on previous attempts or self-declaration)
* Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)
* Concurrent participation in another clinical trial using any investigational drug or device
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03356002
Study Brief:
Protocol Section:
NCT03356002