Use of Goggle Balloon to Improve Cecal Intubation During... | NCT02359409

Studies
Use of Goggle Balloon to Improve Cecal Intubation During Colonoscopy

NCT02359409

Sponsor

Indiana University

Status

Withdrawn

Last Update Posted

Apr 28, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Redundant Colon

Interventions

goggle balloon
water immersion only

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

Apr 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no subjects consented due to competing studies

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Mar 28, 2017Actual

Completion Date

Mar 28, 2017Actual

First Submitted Date

Jan 30, 2015

First Submission Date that Met QC Criteria

Feb 4, 2015

First Posted Date

Feb 10, 2015Estimated

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

Apr 27, 2017

Last Update Posted Date

Apr 28, 2017Actual

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 look if use of goggle balloon can help to complete colonoscopy in patients with very redundant colons.

Detailed Description

About 5% of colonoscopies are technically difficult because the colon is elongated or redundant. There is an increased risk of the colonoscope not reaching the cecum in these cases. One solution to this is to try to keep the colon shorter by not insufflating it with gas. In order to achieve that, in these cases the investigators typically fill the colon with water, which does not distend the colon as much. Another technique, which can improve visualization, is to use a device called the goggle balloon. This is a small balloon filled with a few mL of water which fits over the end of the colonoscope and pushes the colonic mucosa away from the end of the scope so that the luminal direction can be visualized with minimal insufflation. In patients with normal colons, the goggle balloon can be used to insert the colonoscope to the cecum with virtually no air or water filling. We aim to study if the goggle balloon can be used to help complete the colonoscopy in patients with redundant colons.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
water immersion only	Active Comparator	Colonoscopy will be performed using the water immersion technique.	Other: water immersion only
water immersion with goggle balloon	Experimental	Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique	Device: goggle balloon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
goggle balloon	Device	Colonoscopy will be performed using the water immersion technique.	water immersion with goggle balloon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of subjects with complete colonoscopy in each arm		2 years

Secondary Outcomes

Measure	Description	Time Frame
Time to cecal intubation in each arm		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Referral for incomplete colonoscopy

Exclusion Criteria:

Known stricture or narrowing of the colon, prior colon resection

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Douglas K Rex, MD	IU Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University Hospital		Indianapolis	Indiana	46202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided