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Trial record 45 of 226 for:    "Barrett syndrome"

Early Increase in Blood Supply in Patients With Barrett's Esophagus (EIBS in BE)

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ClinicalTrials.gov Identifier: NCT01188980
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Herbert C. Wolfsen, Mayo Clinic

Brief Summary:
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.

Condition or disease
Barrett's Esophagus

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detectable Esophageal Early Increase in Blood Supply (EIBS) in Patients With Barrett's Esophagus
Study Start Date : June 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Group/Cohort
NoBE (control)
BE without dysplasia
BE with dysplasia



Primary Outcome Measures :
  1. determine if early increase blood supply (EIBS)can predict presence of Dysplasia [ Time Frame: 10 minutes during standard upper endoscopy ]
    To determine if early increase blood supply (EIBS), as measured in Barrett's glandular mucosa segment, can predict the presence of Dysplasia in patients with known diagnosis of Barrett's esophagus (BE).


Secondary Outcome Measures :
  1. determine if EIBS can predict presence of BE in patients undergoing upper endoscopy [ Time Frame: 10 minutes ]
    EIBS measurements taken from buccal mucosa and esophagus will be compared in patients without BE, patients with BE without dysplasia, and patients with BE dysplasia. EIBS measurements will be obtained from normal squamous mucosa in the mouth, proximal esophagus, areas of BE in the distal esophagus, and measurements from the gastric cardia/hiatal hernia (at least 4 cm below the Z line.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Control Population: Patients with no Barrett's metaplasia scheduled for upper endoscopy at Mayo Clinic Jacksonville.

Experimental Population: Patients with biopsy-proven Barrett's esophagus and previously scheduled for upper endoscopy at Mayo Clinic Jacksonville.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188980


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic

Responsible Party: Herbert C. Wolfsen, Professor of Medicine, Mayo College of Medicine, Director of Endoscopy, Mayo Clinic Florida, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01188980     History of Changes
Other Study ID Numbers: 09-005328
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases