Data Collection for CV-3E AI Software Development

Data Collection for CapsoView AI Software Development for the CapsoCam® Colon (CV-3E)

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

Study Overview

• Status: Completed
• Conditions: Colonic Polyps
• Intervention / Treatment: Device: Colon Capsule

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Participants; All participants will swallow the CapsoCam® Colon (CV-3E).	Device: Colon Capsule; All participants will swallow the CapsoCam® Colon (CV-3E) for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect Capsule Images	No assessment will be done for this protocol. Videos will be collected for AI development for use in future study.	4-6 months

Collaborators and Investigators

• Sponsor: Capso Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2025
• Primary Completion (Actual): June 6, 2025
• Study Completion (Actual): June 6, 2025

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: CLN-CVI-7472

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No