CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 459 enrolled
Drug / intervention
Sedated Endoscopy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01288612
NCT01288612N/ACompleted
CompareCT.gov

Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus

Mayo Clinic·interventional·Posted Feb 2, 2011·Updated Jan 7, 2015

In Brief

A clinical study evaluating Sedated Endoscopy and Transnasal Endoscopy for Barrett's Esophagus. Completed, enrolled 459 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBarrett's Esophagus
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Advancing Translational Sciences (NCATS), American College of Gastroenterology

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2011
Enrollment StartFeb 1, 2011
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.4 years ago

Interventions

Sedated Endoscopydevice

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.

Transnasal Endoscopydevice

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.