Clinical trial · Interventional
Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus
NCT04301986CI-TRIAL-00066217completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| GERD | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytosponge | Device | — | UNRESOLVED |
| Esophagogastroduodenoscopy | Device | — | UNRESOLVED |
| Transnasal Endoscopy (TNE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TNE Followed by EGD
- description
- 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.
- interventionNames
- Device: Transnasal Endoscopy (TNE)
- Device: Esophagogastroduodenoscopy
- type
- EXPERIMENTAL
- label
- Cytosponge, then TNE, followed by EGD
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.