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To assess patient acceptance and preference among screening modalities, Esophagogastroduodenoscopy (EGD), Transnasal Esophagoscopy (TNE), and Cytosponge for Barrett's esophagus (BE). 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.
Potential subjects will be identified via protocol and Institutional Review Board (IRB) methods prior to obtaining written informed consent. Once written informed consent is obtained and baseline demographic and medical history is collected, 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Start Date
August 11, 2020
Primary Completion Date
May 10, 2022
Completion Date
May 10, 2022
Last Updated
May 8, 2023
24
ACTUAL participants
Cytosponge
DEVICE
Transnasal Endoscopy (TNE)
DEVICE
Esophagogastroduodenoscopy
DEVICE
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborators
NCT07310927
NCT06953986
NCT05753748
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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