Evaluation of Proposed EZ2go Complete Bowel Cleansing System
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | April 2013 |
| End Date: | January 2014 |
| Contact: | Nancy Chaffin, CCRC |
| Email: | nchaffin01@bgclinic.com |
| Phone: | 904-680-0871 |
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
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.
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.
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.
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