Confocal Microscopy in Barrett's Esophagus | NCT00587184

Studies
Confocal Microscopy in Barrett's Esophagus

NCT00587184

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Nov 24, 2015Estimated

Enrollment

92Actual

Phase

Not provided

Conditions

Barrett's Esophagus

Interventions

Not provided

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

Nov 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

Jul 2006

Primary Completion Date

Feb 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Jan 4, 2008

First Posted Date

Jan 7, 2008Estimated

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

Nov 23, 2015

Last Update Posted Date

Nov 24, 2015Estimated

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 data review will be done to evaluate the use of confocal microscopy imaging in patients who were seen for clinically indicated endoscopic surveillance and biopsies of Barretts Esophagus

Detailed Description

This retrospective chart review will be done to evaluate the use of confocal microscopy imaging in patients who were seen at Mayo Clinic for clinically indicated endoscopic surveillance and biopsies of BE.

Endoscopy reports and pathology results will be reviewed from 100 patients who have undergone endoscopy. These results will be correlated with images obtained with confocal microscopy at the time of the endoscopy. There will be no patient contact.

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

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		patients who were seen clinically indicated endoscopic surveillance and biopsies of BE and confocal microscopy was performed.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have undergone confocal microscopy at the time of surveillance endoscopy for Barrett's Esophagus

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 had confocal microscopy imaging in patients at the time of or clinically indicated endoscopic surveillance and biopsies of BE.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth K Wang, MD	Mayo Clinic	Principal Investigator

Locations

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