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Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

NCT04573959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-10-05

No results posted yet for this study

Summary

To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

Conditions

  • Intestinal Disease
  • Inflammatory Bowel Diseases
  • Crohn Disease
  • Ulcer
  • Celiac Disease

Interventions

DEVICE

SV-3 Capsule Endoscopy

The purpose of this study is to validate an updated version of the CapsoCam SV-3 Endoscopy System with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam SV-3 capsule endoscopy.

Sponsors & Collaborators

  • Generic Devices Consulting, Inc.

    collaborator INDUSTRY

  • Capso Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • David Shields, MD · CapsoVision Research Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2020-06-11
Completion
2020-06-11
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04573959 on ClinicalTrials.gov