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Swallow a camera to check for colon polyps? new study tests it

NCT ID NCT07089615

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

45 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Advanced Research Institute

    RECRUITING

    St. Petersburg, Florida, 33710, United States

  • Digestive Health Services

    RECRUITING

    Downers Grove, Illinois, 60515, United States

  • Gastro Care Institute

    RECRUITING

    Lancaster, California, 93534, United States

  • Gastroenterology Group of Rochester

    RECRUITING

    Rochester, New York, 14618, United States

  • Gastroenterology and Internal Medicine Specialists

    RECRUITING

    Lake Barrington, Illinois, 60010, United States

  • Great Lakes Gastroenterology Research

    RECRUITING

    Mentor, Ohio, 44060, United States

  • Knowledge Research Center

    RECRUITING

    Orange, California, 92868, United States

  • Northshore Center for Gastroenterology

    RECRUITING

    Libertyville, Illinois, 60048, United States

  • SB Gastro Clinical Research

    RECRUITING

    Chula Vista, California, 91910, United States

  • Southwest Gastroenterology

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Suburban Gastroenterology

    RECRUITING

    Naperville, Illinois, 60540, United States

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