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The Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Oesophagus

NCT02498041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2015-07-15

No results posted yet for this study

Summary

This study evaluates the diagnostic accuracy, safety and acceptability of transnasal endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be randomised to receive either TNE or standard endoscopy followed by the other procedure.

Conditions

  • Barrett's Esophagus
  • Dyspepsia

Interventions

PROCEDURE

Transnasal Endoscopy

Experimental procedure with transnasal endoscopy for the first 80% of the patients (n=90). The examination is limited to the esophagus and the proximal stomach.

DEVICE

Office-based disposable transnasal endoscopy Endosheath

Experimental procedure with portable, disposable transnasal endoscopy for the last 20% of patients only (n=25). The examination is limited to the esophagus and the proximal stomach.

DEVICE

Standard upper GI endoscopy

Upper GI endoscopy with standard gastroscope.

PROCEDURE

Esophageal biopsies

2 research biopsies taken if endoscopic evidence of columnar-lined esophagus

Sponsors & Collaborators

Principal Investigators

  • Rebecca C Fitzgerald, MD · University of Cambridge

  • M. Kareem Shariff, MRCP · University of Cambridge

  • Massimiliano di Pietro, MD · University of Cambridge

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-07-31
Completion
2013-07-31

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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 NCT02498041 on ClinicalTrials.gov