Data Collection for CV-3E AI Software Development

NCT06916845 | Completed FDA Device

• 1 other identifier: CLN-CVI-7472
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 4

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

Outcome Measures

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.

  4-6 months

Study Arms (1)

All Participants

EXPERIMENTAL

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

Device: Colon Capsule

Interventions

Colon Capsule DEVICE

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

All Participants

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Choose to participate and must have signed the IRB-approved informed consent document.

You may not qualify if:

• Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
• Colonoscopy within the past 4 years that demonstrated polyps that were removed.
• Has contraindication for capsule endoscopy
• Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
• Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
• History of incomplete colonoscopy
• 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).
• Impaired cardiac function assessed as greater than NYHA Class II
• History of small- or large-bowel obstructive condition
• Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
• 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
• Known allergy to ingredients used in bowel preparation and boosters
• Daily and/or regular narcotic use
• Decompensated cirrhosis
• Prior abdominal radiation therapy

Sponsors & Collaborators

• Capso Vision, Inc.: lead

Study Sites (4)

Advanced Research Institute Inc

New Port Richey, Florida, 34653, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States

Location

Digestive Diseases Center of Hattiesburg, LLC

Hattiesburg, Mississippi, 39402, United States

Location

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 8, 2025
• Study Start: March 16, 2025
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)