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CompletedNCT01838408Updated Jan 27, 2015

Evaluation of Proposed EZ2go Complete Bowel Cleansing System

An interventional study of Ez2go Complete and LoSo Prep in Screening Colonoscopy, Surveillance Colonoscopy and Colonoscopy, sponsored by Borland-Groover Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-27.

Sponsored by Borland-Groover Clinic · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Screening Colonoscopy
  • Surveillance Colonoscopy
  • Colonoscopy

Keywords

  • screening colonoscopy
  • surveillance colonoscopy
  • colonoscopy
03

In context

Lead sponsor

This is the only study on the registry with Borland-Groover Clinic as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    EZ2go Complete

    EZ2go complete: Peg 3350, Magnesium Citrate and Simethicone

    Other: Ez2go Complete

  • Active comparator
    LoSo Prep ™

    LoSo Prep ™: Magnesium citrate and Bisacodyl

    Other: LoSo Prep

Interventions

  • OtherEz2go Complete

    EZ2Go Complete

  • OtherLoSo Prep

    LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm

06

What researchers measure

Primary outcomes

  1. Measurement of Efficacy

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

    Time frame: 24 hours

Secondary outcomes

  1. 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.

    Time frame: 2 weeks

07

Study locations

1 site
  • Borland-Groover Clinic
    Jacksonville, Florida 32256, United States
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01838408
Lead sponsor
Borland-Groover Clinic
Collaborators
Valley Medical Products, LLC is paying for the study and is the sponsor. The form would not go through with this listed.
Responsible party
Sponsor
First posted
Apr 24, 2013
Start date
Apr 2013
Primary completion
Apr 2014
Completion
Jun 2014
Last update
Jan 27, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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