Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barrett's Esophagus (challenge)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01288612
First received: January 28, 2011
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

That the comparative effectiveness of unsedated transnasal endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for BE.


Condition Intervention
Barrett's Esophagus
Device: sedated EGD
Device: transnasal endoscopy in clinic
Device: transnasal endoscopy mobile

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barrett's Esophagus

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • proportion of subjects who undergo esophageal assessment in the three cohorts in response to invitation for screening. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: February 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sedated EGD
Sedated Esophagogastroduodenoscopy with biopsy
Device: sedated EGD
Sedated Esophagogastroduodenoscopy with biopsy
Active Comparator: transnasal endoscopy at clinic
Unsedated transnasal endoscopy at clinic
Device: transnasal endoscopy in clinic
unsedated transnasal endoscopy performed in clinical research unit
Active Comparator: transnasal endoscopy mobile
unsedated transnasal endoscopy in mobile research van
Device: transnasal endoscopy mobile
unsedated transnasal endoscopy performed in mobile research van

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Olmsted county resident, MN
  • age 50 or older
  • able to give informed consent

Exclusion Criteria:

  • History of known barrett's esophagus (BE)or endoscopy within the last 10 years
  • History of progressive dysphagia
  • known Zenker's or epiphrenic diverticulum
  • history of recurrent epistaxis
  • illnesses that impair ability to complete questionnaires (e.g. metastatic cancer, stroke, dementia)
  • contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288612

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Prasad G. Iyer, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01288612     History of Changes
Other Study ID Numbers: 10-007787
Study First Received: January 28, 2011
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's esophagus

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on April 17, 2014