Evaluation of Proposed EZ2go Complete Bowel Cleansing System

Borland-Groover Clinic

Status

Completed

Conditions

Surveillance Colonoscopy

Screening Colonoscopy

Colonoscopy

Treatments

Other: LoSo Prep

Other: Ez2go Complete

Study type

Interventional

Funder types

Other

Identifiers

NCT01838408

Pro00008184

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.