Swallow a camera to check for colon polyps? new study tests it
NCT ID NCT07089615
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new capsule camera (CapsoCam Colon) that you swallow to detect colon polyps. About 330 adults aged 45-75 will swallow the capsule and then have a standard colonoscopy for comparison. The goal is to see if the capsule, with AI help, can accurately find polyps as well as colonoscopy does.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CapsoCam Colon (CV-3) capsule endoscope system
- What this could lead to
- If successful, this could provide a less invasive option for colon polyp screening, potentially making detection easier and more accessible.
- What could go wrong
- This is a mid-stage study with 330 participants, and the capsule may miss some polyps or cause discomfort. It is not yet proven to replace colonoscopy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 330 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 45-75 years of age 2. Committed to undergo a colonoscopy. 3. Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor Exclusion Criteria: 1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps 2. Has contraindication for capsule endoscopy or colonoscopy 3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome 4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease 5. History of incomplete colonoscopy 6. Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C\>6.4 within the past 3 months and/or with history of constipation or gastroparesis). 7. Impaired cardiac function assessed as greater than NYHA Class II 8. History of small- or large-bowel obstructive condition 9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis 10. 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 subject at greater risk for capsule endoscope retention 11. Known allergy to ingredients used in bowel preparation and boosters 12. Daily and/or regular narcotic use 13. Decompensated cirrhosis 14. Prior abdominal radiation therapy 15. Diagnosis of anorexia or bulimia 16. History of or suspicion of any of the following: strictures, volvulus or intestinal obstruction, or internal hernias or abdominal surgeries that the Investigator believes should exclude the patient from study participation 17. Known or suspected megacolon 18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule 19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis 20. Pregnant or nursing or of child-bearing potential and does not agree to practice medically acceptable methods of contraception. Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at screening. 21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures 22. Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study or would affect the validity of the study results 23. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study 24. Chronic constipation as defined by \<3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Advanced Research Institute
RECRUITINGSt. Petersburg, Florida, 33710, United States
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Digestive Health Services
RECRUITINGDowners Grove, Illinois, 60515, United States
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Gastro Care Institute
RECRUITINGLancaster, California, 93534, United States
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Gastroenterology Group of Rochester
RECRUITINGRochester, New York, 14618, United States
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Gastroenterology and Internal Medicine Specialists
RECRUITINGLake Barrington, Illinois, 60010, United States
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Great Lakes Gastroenterology Research
RECRUITINGMentor, Ohio, 44060, United States
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Knowledge Research Center
RECRUITINGOrange, California, 92868, United States
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Northshore Center for Gastroenterology
RECRUITINGLibertyville, Illinois, 60048, United States
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SB Gastro Clinical Research
RECRUITINGChula Vista, California, 91910, United States
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Southwest Gastroenterology
RECRUITINGOak Lawn, Illinois, 60453, United States
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Suburban Gastroenterology
RECRUITINGNaperville, Illinois, 60540, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Flushing the right colon Mid-Procedure: a new way to catch hidden polyps?
- New camera modes could sharpen Colonoscopy's eye for precancerous polyps
- AI eye for colonoscopy: could software catch what doctors miss?
- Web tool aims to spot hidden cancer in large colon polyps without special equipment
- AI eye on your colon: can software spot polyps better?
- AI aims to improve colon polyp measurement for cancer prevention