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Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus

NCT01288612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2015-01-07

Study results available
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Summary

The hypothesis of this study was that the comparative effectiveness of unsedated transnasal endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for BE.

Conditions

  • Barrett's Esophagus

Interventions

DEVICE

Sedated Endoscopy

The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.

DEVICE

Transnasal Endoscopy

Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • American College of Gastroenterology

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Prasad G. Iyer, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01288612 on ClinicalTrials.gov