Evaluation of Proposed EZ2go Complete Bowel Cleansing System

Borland-Groover Clinic185 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

185

Conditions

Screening Colonoscopy Surveillance Colonoscopy Colonoscopy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Measurement of Efficacy

The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.

Time frame: 24 hours

Secondary Outcomes

Evaluate the safety

A basic metabolic panel will be drawn at baseline and after the bowel preparation is complete to evaluate for any electrolyte and renal disturbances.

Time frame: 2 weeks