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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01288612
First received: January 28, 2011
Last updated: June 23, 2014
Last verified: June 2014
  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 ]

Enrollment: 450
Study Start Date: February 2011
Study Completion Date: October 2013
Primary Completion Date: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's esophagus

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

ClinicalTrials.gov processed this record on November 19, 2014