Evaluation of Proposed EZ2go Complete Bowel Cleansing System | NCT01838408

Studies
Evaluation of Proposed EZ2go Complete Bowel Cleansing System

NCT01838408

Sponsor

Borland-Groover Clinic

Status

Completed

Last Update Posted

Jan 27, 2015Estimated

Enrollment

185Actual

Phase

Not Applicable

Conditions

Screening Colonoscopy
Surveillance Colonoscopy
Colonoscopy

Interventions

Ez2go Complete
LoSo Prep

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Apr 16, 2013

First Submission Date that Met QC Criteria

Apr 23, 2013

First Posted Date

Apr 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2015

Last Update Posted Date

Jan 27, 2015Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

185Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EZ2go Complete	Experimental	EZ2go complete: Peg 3350, Magnesium Citrate and Simethicone	Other: Ez2go Complete
LoSo Prep ™	Active Comparator	LoSo Prep ™: Magnesium citrate and Bisacodyl	Other: LoSo Prep

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ez2go Complete	Other	EZ2Go Complete	EZ2go Complete
LoSo Prep

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided