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TNE Followed by EGD for Barrett's Esophagus

N/A
Waitlist Available
Led By Swathi Eluri, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, post-procedure (<24 hours of procedure completion)
Awards & highlights

Study Summary

This trial is testing how well three different screening modalities work for Barrett's esophagus, and how patients feel about each one.

Eligible Conditions
  • Barrett's Esophagus
  • Acid Reflux

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, post-procedure (<24 hours of procedure completion)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, post-procedure (<24 hours of procedure completion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
7 Days Post-EGD Impact of Events Score (IES)
Secondary outcome measures
7 Days Post-EGD Ranking of Preferred Screening Modality
7 Days Post-EGD Willingness to Repeat
Factors Influencing the Preferred Screening Modality
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: TNE Followed by EGDExperimental Treatment2 Interventions
Subjects will undergo administration of a transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected.
Group II: Cytosponge, then TNE, followed by EGDExperimental Treatment3 Interventions
Subjects will undergo administration of Cytosponge and transnasal endoscopy (TNE) prior to their scheduled clinically indicated upper endoscopy performed per routine standard of care. Following the procedure, a follow-up phone call will be made during which an impact of events scale related to the subjective distress of each procedure, a preference and acceptance questionnaire, and adverse events related to study participation will be collected.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esophagogastroduodenoscopy
2017
Completed Phase 3
~980
Cytosponge
2014
N/A
~190
Transnasal Endoscopy (TNE)
2020
N/A
~30

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,018 Total Patients Enrolled
American Gastroenterological AssociationOTHER
5 Previous Clinical Trials
4,395 Total Patients Enrolled
Swathi Eluri, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
75 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
2020. "Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04301986.
~5 spots leftby Apr 2025
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