Evaluation of Proposed EZ2go Complete Bowel Cleansing System

Completed · Not applicable

Conditions studied: Screening Colonoscopy, Surveillance Colonoscopy, Colonoscopy

In brief

This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. The investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more accessible way (over-the-counter). To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination versus currently available over-the-counter bowel preparations. The investigators believe the EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.

Key facts

Study ID

NCT01838408

Run by

Borland-Groover Clinic

People needed

185

Starts

2013-04-01

Expected to finish

2014-06-01

Last updated by the study team

2015-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients referred for routine colorectal cancer screening or surveillance colonoscopy examinations.
• Male and Female participants 18 years of age and older.
• Female participants who are not pregnant or planning to become pregnant within the next 90 days, or are sterile or of non-childbearing potential.
• Negative urine test at the screening visit.
• Subject is able to read and understand the informed consent form and signs the informed consent form.

You may not qualify if…

• Contraindication to any of the bowel preparations being used in the study.
• Unable/unwilling to fill out patient questionnaires following procedure.
• Pregnant or lactating.
• Unwilling to perform indicated lab work.
• Lab results that would indicate stage 4-5 chronic kidney disease (GFR <30MI/min1.73 m2).
• Personal history of colorectal cancer.
• Personal history of colorectal or small bowel surgery.
• Participants have any condition that, in the investigators opinion, could interfere with the participation and completion of this study.

Where it is running

• Borland-Groover Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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