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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 24, 2010
First Posted Date August 26, 2010
Last Update Posted Date April 22, 2016
Study Start Date June 2010
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2013)
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).
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 26, 2013)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Increase in Blood Supply in Patients With Barrett's Esophagus
Official Title Detectable Esophageal Early Increase in Blood Supply (EIBS) in Patients With Barrett's Esophagus
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Barrett's Esophagus
Intervention Not Provided
Study Groups/Cohorts
  • NoBE (control)
  • BE without dysplasia
  • BE with dysplasia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 26, 2013)
90
Original Estimated Enrollment
 (submitted: August 25, 2010)
30
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01188980
Other Study ID Numbers 09-005328
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Herbert C. Wolfsen, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators Not Provided
PRS Account Mayo Clinic
Verification Date April 2016