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Data Collection for CV-3E AI Software Development

NCT06916845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-07-03

No results posted yet for this 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

Conditions

  • Colonic Polyps

Interventions

DEVICE

Colon Capsule

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

Sponsors & Collaborators

  • Capso Vision, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-16
Primary Completion
2025-06-06
Completion
2025-06-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06916845 on ClinicalTrials.gov