Evaluation of Proposed EZ2go Complete Bowel Cleansing System

Randomized, Single Blinded Study of Proposed EZ2go Complete Bowel Cleansing System: Evaluation of Its Safety, Efficacy and Patient Tolerance Compared to LOSO Prep, an Over the Counter Laxative Kit for Colonoscopy Bowel Preparation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01838408

Enrollment

185

Registered

2013-04-24

Start date

2013-04-30

Completion date

2014-06-30

Last updated

2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Screening Colonoscopy, Surveillance Colonoscopy

Keywords

screening colonoscopy, surveillance colonoscopy, colonoscopy

Brief summary

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.

Interventions

OTHEREz2go Complete

EZ2Go Complete

OTHERLoSo Prep

LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Measurement of Efficacy	24 hours	The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.

Secondary

Measure	Time frame	Description
Evaluate the safety	2 weeks	A basic metabolic panel will be drawn at baseline and after the bowel preparation is complete to evaluate for any electrolyte and renal disturbances.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026