Data Collection for CV-3E AI Software Development

NCT ID: NCT06916845

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-16
• Study Completion Date: 2025-06-06

Brief 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

Conditions

Colonic Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

All Participants

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

Group Type: EXPERIMENTAL

Colon Capsule

Intervention Type: DEVICE

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

Interventions

Colon Capsule

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Capso Vision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Advanced Research Institute Inc

New Port Richey, Florida, United States

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, United States

Digestive Diseases Center of Hattiesburg, LLC

Hattiesburg, Mississippi, United States

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia, United States

Countries

United States

Other Identifiers

CLN-CVI-7472

Identifier Type: -

Identifier Source: org_study_id