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CompletedNCT06916845Updated Jul 3, 2025

Data Collection for CV-3E AI Software Development

An interventional study of Colon Capsule in Colonic Polyps, sponsored by Capso Vision, Inc.. Completed at 4 sites in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by Capso Vision, Inc. · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Jun 2025, 1 year 4 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Not applicable
Ages
45 Years to 75 Years
Sex
All
01

Study summary

The goal of this clinical trial is to collect capsule images for the development of CADe software for use with the CapsoCam® Colon (CV-3E) in healthy volunteers who have been referred for colonoscopy. There will be no analysis performed as part of this protocol.

Participants will

  • adhere to bowel prep instructions and dietary requirements
  • ingest pro-kinetic medication and CapsoCam® Colon (CV-3E)
  • adhere to booster regimen and dietary requirements until capsule passes
  • retrieve capsule with retrieval kit per instructions and mail back to sponsor
  • participate in follow-up phone call
02

Conditions studied

  • Colonic Polyps

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03

In context

Colonic Polyps

318 studies on the registry are indexed under Colonic Polyps; 54 are open to participants now.

This study's enrollment of 86 is below the median of 270 across 215 interventional studies indexed under Colonic Polyps.

Browse Colonic Polyps studies →

Lead sponsor

Capso Vision, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 45-75 years of age
  2. Choose to participate and must have signed the IRB-approved informed consent document.

Exclusion criteria

Exclusion Criteria:

  1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
  2. Colonoscopy within the past 4 years that demonstrated polyps that were removed.
  3. Has contraindication for capsule endoscopy
  4. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
  5. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
  6. History of incomplete colonoscopy
  7. 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).
  8. Impaired cardiac function assessed as greater than NYHA Class II
  9. History of small- or large-bowel obstructive condition
  10. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
  11. 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
  12. Known allergy to ingredients used in bowel preparation and boosters
  13. Daily and/or regular narcotic use
  14. Decompensated cirrhosis
  15. Prior abdominal radiation therapy
  16. Diagnosis of anorexia or bulimia
  17. 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
  18. Known or suspected megacolon
  19. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
  20. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
  21. 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.
  22. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
  23. 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
  24. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
  25. Chronic constipation as defined by \<3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    All Participants

    All participants will swallow the CapsoCam® Colon (CV-3E).

    Device: Colon Capsule

Interventions

  • DeviceColon Capsule

    All participants will swallow the CapsoCam® Colon (CV-3E) for this study.

06

What researchers measure

Primary outcomes

  1. Collect Capsule Images

    No assessment will be done for this protocol. Videos will be collected for AI development for use in future study.

    Time frame: 4-6 months

07

Study locations

4 sites
  • Advanced Research Institute Inc
    New Port Richey, Florida 34653, United States
  • Advanced Gastroenterology Associates, LLC
    Palm Harbor, Florida 34684, United States
  • Digestive Diseases Center of Hattiesburg, LLC
    Hattiesburg, Mississippi 39402, United States
  • Gastroenterology Consultants of Southwest Virginia
    Roanoke, Virginia 24014, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06916845
Lead sponsor
Capso Vision, Inc.
Responsible party
Sponsor
First posted
Apr 8, 2025
Start date
Mar 16, 2025
Primary completion
Jun 6, 2025
Completion
Jun 6, 2025
Last update
Jul 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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