Early Increase in Blood Supply in Patients With Barrett's Esophagus

NCT ID: NCT01188980

Last Updated: 2016-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study is to determine if early Barrett's specialized intestinal metaplasia can be detected by measuring early increased blood supply of the esophageal tissue, with 4 Dimensional Elastic Light-Scattering Fingerprinting, (4D-ELF) technology in real time.

Detailed Description

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Conditions

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Barrett's Esophagus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NoBE (control)

No interventions assigned to this group

BE without dysplasia

No interventions assigned to this group

BE with dysplasia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age 18 years or older,
* informed written consent,
* patient scheduled for previously planned upper endoscopy

Exclusion Criteria

* liver disease;
* gastric antral vascular ectasia (GAVE);any known non-esophageal aerodigestive malignancy;
* severe cardiopulmonary disease precluding endoscopy; presence of conditions not allowing biopsy (e.g. coagulation disorder);
* known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc.);
* known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Herbert C. Wolfsen

Professor of Medicine, Mayo College of Medicine, Director of Endoscopy, Mayo Clinic Florida

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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09-005328

Identifier Type: -

Identifier Source: org_study_id

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