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Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

NCT04607746 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1337

Last updated 2025-07-08

No results posted yet for this study

Summary

This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.

Conditions

  • Colonic Polyp

Interventions

DEVICE

Capsule Endoscope

Capsule endoscope used to view colonic mucosa

Sponsors & Collaborators

  • Capso Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • David Shields, MD · Gastroenterology Consultant at San Mateo County Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-06
Primary Completion
2025-02-14
Completion
2025-02-14
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 NCT04607746 on ClinicalTrials.gov