Status:
COMPLETED
Evaluation of Proposed EZ2go Complete Bowel Cleansing System
Lead Sponsor:
Borland-Groover Clinic
Collaborating Sponsors:
Valley Medical Products, LLC is paying for the study and is the sponsor. The form would not go through with this listed.
Conditions:
Screening Colonoscopy
Surveillance Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01838408
Start Date
April 1 2013
End Date
June 1 2014
Last Update
January 27 2015
Active Locations (1)
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1
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256