Status:
COMPLETED
Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
American Gastroenterological Association
Conditions:
Barrett Esophagus
GERD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To assess patient acceptance and preference among screening modalities, Esophagogastroduodenoscopy (EGD), Transnasal Esophagoscopy (TNE), and Cytosponge for Barrett's esophagus (BE). Subjects will und...
Detailed Description
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 demo...
Eligibility Criteria
Inclusion
- Patients with one of the following: Gastroesophageal Reflux Disease (GERD) OR Barrett's esophagus (BE)
- At least 18 years of age at time of consent
- Able and willing to provide written informed consent
- Able and willing to comply with required study procedures and follow-up schedule
- Presenting to UNC Hospitals for routine care upper endoscopy
Exclusion
- History of pre-existing esophageal stenosis/ stricture, esophageal diverticulum or significant esophageal anatomic abnormalities (masses, obstructive lesions, etc.)
- History of head and neck malignancy or anatomical abnormalities of the nasopharynx
- Any history of Ear, Nose and Throat (ENT) surgery
- History of significant epistaxis or hereditary hemorrhagic telangiectasia (HHT)
- Sinus or pulmonary infection in the last 4 weeks
- Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or low molecular weight heparin (requires discontinuation of medication 7 days prior to and 7 days after esophagogastroduodenoscopy \[EGD\] and Cytosponge administration, aspirin use is OK).
- Known bleeding disorder
- Pregnancy, or planned pregnancy during the course of the study.
- Any history of esophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B \& C) or evidence of varices noted on any past endoscopy
- Any history of esophageal surgery, except for uncomplicated fundoplication
- History of coagulopathy, with international normalised ratio (INR) \>1.3 and/or platelet count of \<75,000
- General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
- Subject has any condition that, in the opinion of the investigator or sponsor, would interfere with accurate interpretation of the study objectives or preclude participation in the trial
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04301986
Start Date
August 11 2020
End Date
May 10 2022
Last Update
May 8 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599