Clearpath Miniprep Colonoscopy Study | NCT01374945

Studies
Clearpath Miniprep Colonoscopy Study

NCT01374945

Sponsor

EasyGlide

Status

Withdrawn

Last Update Posted

Feb 27, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Colonoscopy

Interventions

Clearpath Lower GI

Countries

Not provided

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

Feb 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawn for business reasons

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 15, 2011

First Submission Date that Met QC Criteria

Jun 15, 2011

First Posted Date

Jun 16, 2011Estimated

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

Feb 26, 2013

Last Update Posted Date

Feb 27, 2013Estimated

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

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SOC preparation and colonoscopy	No Intervention
Miniprep and Clearpath	Experimental		Device: Clearpath Lower GI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clearpath Lower GI	Device	Clearpath device for cleaning of colon by irrigation and evacuation	Miniprep and Clearpath

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient 18-70 years
Scheduled for colonoscopy
Providing informed consent

Exclusion Criteria:

Known large polyps (> 2 cm) for polypectomy
Inflammatory Bowel Disease (IBD)
Previous colonic surgery
Known or suspected stricture
Significant co morbidity
Significant diverticular disease
Contraindicated to receive oral Sodium Picosulfate solution

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided