NCT01288612

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 7, 2015

Completed
Last Updated

January 7, 2015

Status Verified

December 1, 2014

Enrollment Period

2.7 years

First QC Date

January 28, 2011

Results QC Date

December 23, 2014

Last Update Submit

December 23, 2014

Conditions

Barrett's Esophagus

Keywords

Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment

    This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.

    Approximately 2 weeks after invitation letter was sent

Secondary Outcomes (7)

  • Rate of Successful Intubation

    Visit 1

  • Rate of Complete Evaluation

    Visit 1

  • Rate of Acquisition of Biopsies From the Esophagus

    Visit 1

  • Mean Duration of Procedure

    Visit 1

  • Mean Time From Extubation to Discharge

    Visit 1

  • +2 more secondary outcomes

Study Arms (3)

Sedated Endoscopy

ACTIVE COMPARATOR

Sedated esophagogastroduodenoscopy with biopsy

Device: Sedated Endoscopy

Transnasal Endoscopy at Hospital Unit

ACTIVE COMPARATOR

Unsedated transnasal endoscopy at hospital unit.

Device: Transnasal Endoscopy

Transnasal Endoscopy at Mobile Unit

ACTIVE COMPARATOR

Unsedated transnasal endoscopy in mobile research van

Device: Transnasal Endoscopy

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.

Sedated Endoscopy
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.

Transnasal Endoscopy at Hospital UnitTransnasal Endoscopy at Mobile Unit

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Olmsted county, Minnesota resident
  • Age 50 or older
  • Able to give informed consent

You may not qualify if:

  • History of known Barretts Esophagus (BE) or endoscopy within the last 10 years
  • History of progressive dysphagia
  • Known Zenkers 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Sami SS, Dunagan KT, Johnson ML, Schleck CD, Shah ND, Zinsmeister AR, Wongkeesong LM, Wang KK, Katzka DA, Ragunath K, Iyer PG. A randomized comparative effectiveness trial of novel endoscopic techniques and approaches for Barrett's esophagus screening in the community. Am J Gastroenterol. 2015 Jan;110(1):148-58. doi: 10.1038/ajg.2014.362. Epub 2014 Dec 9.

    PMID: 25488897RESULT

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Prasad G. Iyer
Organization
Mayo Clinic
iyer.prasad@mayo.edu
507-284-6469

Study Officials

  • Prasad G. Iyer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 28, 2011

First Posted

February 2, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 7, 2015

Results First Posted

January 7, 2015

Record last verified: 2014-12

Locations

US(1)