CapsoCam® Colon Capsule Endoscope (CCE) Compared to Colonoscopy (OC)
United States112 participantsStarted 2020-01-25
Plain-language summary
This non-significant risk pilot study is designed to evaluate safety and performance of the CapsoCam® Colon capsule endoscope in patients who meet the eligibility criteria and are scheduled for colonoscopy.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Between the ages of 50 and 75 years old
. Subject meets at least one of the following criteria for increased risk for polyps:
. Recent history (within 6 months) of positive FIT/iFOBT or Cologuard test
. Older than 55 years of age, without prior history of colonoscopy
. Has had a positive colonoscopy ≥ 5 years prior to screening visit
. And/or having at least two of the following risk factors:
. No contraindication for capsule endoscopy or colonoscopy
. Committed to undergo a colonoscopy, independent of this study within 8 weeks of Capsule ingestion
Exclusion criteria
. History of negative colonoscopy within the last 10 years
. History of incomplete colonoscopy
. Impaired cardiac function assessed as greater than NYHA Class II
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. History of small- or large-bowel obstructive condition
. Known history of Crohn's disease, swallowing disorder, ulcerative colitis, ischemic bowel disease and/or radiation enteritis
. Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the patient at greater risk for capsule endoscope retention
. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
. Known allergy to ingredients used in bowel preparation and boosters