A Trial Comparing Yield of Confocal Endomicroscopy Guided... | NCT01030263

Studies
A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

NCT01030263

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Mar 25, 2010Estimated

Enrollment

18Actual

Phase

Phase 4

Conditions

Barrett's Esophagus

Interventions

Fluorescence-aided confocal endomicroscopy guided biopsy.
Random four-quadrant biopsies.

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

Mar 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The investigators left the institution.

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Dec 7, 2009

First Submission Date that Met QC Criteria

Dec 9, 2009

First Posted Date

Dec 11, 2009Estimated

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

Mar 24, 2010

Last Update Posted Date

Mar 25, 2010Estimated

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

We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CEM	Experimental	Biopsies obtained with fluorescence-aided confocal endomicroscopy.	Other: Fluorescence-aided confocal endomicroscopy guided biopsy.
RFQ	Other	Random four-quadrant biopsies.	Other: Random four-quadrant biopsies.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluorescence-aided confocal endomicroscopy guided biopsy.	Other	Fluorescence-aided confocal endomicroscopy guided biopsy.	CEM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Whether specialized columnar epithelium was detected.		At biopsy on Day 0.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age at least 18.
Barrett's esophagus
Acid suppressive therapy
Endoscopic surveillance

Exclusion Criteria:

Pregnancy or lactation
Allergy to fluorescein
Endoscopic esophagitis Los Angeles classification A to D
Mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion
Obvious mass lesions or cancer

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ananya Das, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Scottsdale	Arizona		United States

Condition Browse Module

MeSH Terms

ID	Term
D001471	Barrett Esophagus

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided