Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02018367
Brief Summary:
The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).
Detailed Description:
Primary outcomes:
* the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
\- compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions
* the clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia
* does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR)
* the total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary?
Secondary outcomes:
* sensitivity, specificity, positive predictive value, and negative predictive value of HRME for the in-vivo diagnosis of neoplasia in a routine surveillance population of patients with BE (using histopathologic diagnosis of mucosal biopsies as the reference standard)
* the total procedure time for imaging and mucosal biopsy acquisition of HRME - compared with WL, stratified by length of BE (\< 3 cm and \> 3cm)
Study:
NCT02018367
Study Brief:
Protocol Section:
NCT02018367