Pilot to Assess DBE as a Rescue Technique for Failed PEJ | NCT01057940

Studies
Pilot to Assess DBE as a Rescue Technique for Failed PEJ

NCT01057940

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jun 28, 2013Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Patients Who Have Failed Conventional DPEJ Placement

Interventions

DBE PEJ placement

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

Jun 2013

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 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Jan 27, 2010

First Submission Date that Met QC Criteria

Jan 27, 2010

First Posted Date

Jan 28, 2010Estimated

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

Jun 26, 2013

Last Update Posted Date

Jun 28, 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

Description Module

Brief Summary

Is DBE(double balloon enteroscopy)-assisted DPEJ(direct percutaneous endoscopic jejunostomy) a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.

Detailed Description

DBE-assisted DPEJ is a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEJ placement		Patients who have failed conventional DPEJ placement and would otherwise require surgical intervention.	Procedure: DBE PEJ placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DBE PEJ placement	Procedure	One time procedure with follow-up telephone call.	PEJ placement

Eligibility Module

Eligibility Criteria

Patients:

Patients who have failed conventional DPEJ tube placement will be offered participation in the study. DBE-assisted DPEJ will be performed on a subsequent day following failed DPEJ. Patients who do not wish to undergo an attempt at DBE-assisted DPEJ will follow-up with their primary caregiver for alternative means of feeding tube placement (e.g., surgical jejunostomy).

Inclusion criteria:

Age > 18 years old
Appropriate indication for DPEJ tube placement and Nutrition consult approval
Absence of bleeding disorder
Platelet count > 50,000 and INR < 1.5
Ability to give informed consent

Accepts Healthy Volunteers

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

Patients who have failed conventional DPEJ placement

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louis Wong kee song, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States