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Use of a Colon Irrigation Device as a Preparation for a Colon Visualization Procedure

NCT03458390 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-07-31

No results posted yet for this study

Summary

A prospective, single center, study to evaluate the effectiveness of the HyGIeaCare Prep when used in combination with the PillCam COLON; the hypothesis is that the HyGIeaCare Prep will be easier for the patients to tolerate, and the results will be as good as the existing oral preparation.

Conditions

  • Screening Colonoscopy

Interventions

DEVICE

HyGIeaCare colon irrigation

PillCam COLON for visualization of bowel lining

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • HyGIeaCare, Inc.

    lead INDUSTRY

Principal Investigators

  • David A Johnson, MD · Eastern Virginia Medical Center

  • William Stassen, MD · Austin Gastroenterology

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2020-01-19
Completion
2020-01-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03458390 on ClinicalTrials.gov