View clinical trials related to Barrett's Esophagus.
Filter by:To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.
The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).
This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.
This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.
The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE). Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
Subjects presenting to University of North Carolina at Chapel Hill (UNC) Hospitals for routine endoscopic surveillance examinations for current Barrett's Esophagus (BE) or after successful radiofrequency ablation (RFA) of dysplastic Barrett's Esophagus (BE) will be offered enrollment in the study. After informed consent, and the same day as the endoscopic procedure, the subject will undergo administration of the Cytosponge assay. The patient will then undergo routine endoscopic surveillance, using a standard Seattle biopsy surveillance protocol. The Cytosponge will be placed in fixative and shipped to the Fitzgerald laboratory at the University of Cambridge for processing according to their established protocols. Tissue biopsies will undergo standard processing and Hematoxylin and Eosin (H&E) staining, with assessment by expert gastrointestinal pathologists at UNC. The primary outcome variables will be sensitivity and specificity of the novel assay, compared against the gold standard of the presence of recurrent BE as detected by upper endoscopy with biopsies. Secondary outcomes include acceptability of the nonendoscopic assay to the patient (assessed by a standardized tool, the Impact of Events Scale, as well as a visual analogue scale), and likelihood of assay positivity as a function of amount of residual disease (as measured by Prague criteria).
Subjects enrolled in this study will have biopsies obtained and sent to Dr. Fitzgerald's lab for analysis of a validated biomarker panel. Subjects will be stratified to either high or low risk of progression to esophageal adenocarcinoma (EAC) based on biomarker panel results. Biomarker panel results will not be communicated to sites. Subjects with low grade dysplasia will be offered the option of treatment (radiofrequency ablation (RFA)) as part of routine care. Subjects with low grade dysplasia who do not want RFA and subjects with no dysplasia will receive surveillance endoscopy in 1 year per routine care. All subjects will be administered a questionnaire seeking information about hypothetical willingness to be randomized to treatment or surveillance.
This study is to identify potential markers from esophageal biopsies and brush cytology for feasibility of use in stool specimens for detection of Barretts Esophagus.