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OpenTrials
Completed

NCT Number: NCT01838408

Evaluation of Proposed EZ2go Complete Bowel Cleansing System

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.

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Key information

Conditions

Screening Colonoscopy Colonoscopy Surveillance Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ez2go Complete

Other

EZ2Go Complete

LoSo Prep

Other

LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm

Primary outcomes

  1. Measurement of Efficacy

    Time frame: 24 hours

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

Secondary outcomes

  1. Evaluate the safety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Borland-Groover Clinic

Other

Collaborators

  • Valley Medical Products, LLC is paying for the study and is the sponsor. The form would not go through with this listed.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2013
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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