Evaluation of Proposed EZ2go Complete Bowel Cleansing System

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Screening Colonoscopy, Surveillance Colonoscopy, Colonoscopy

Intervention / Treatment
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* Other: Ez2go Complete
* Other: LoSo Prep


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EZ2go Complete<br>EZ2go complete: Peg 3350, Magnesium Citrate and Simethicone | Other: Ez2go Complete<br>* EZ2Go Complete<br>|
| Active Comparator: LoSo Prep ™<br>LoSo Prep ™: Magnesium citrate and Bisacodyl | Other: LoSo Prep<br>* LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening colonoscopy, surveillance colonoscopy, colonoscopy