Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-25 @ 11:02 PM
Study NCT ID:
NCT02018367
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma
Sponsor:
Anandasabapathy, Sharmila, M.D.
Organization:
Study Overview
Official Title:
Accuracy, Yield and Clinical Impact of a Low-Cost High Resolution Microendoscope in the Early Diagnosis of Esophageal Adenocarcinoma
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: