Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-03-15 @ 3:29 AM
Study NCT ID:
NCT01862666
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2013-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Volumetric Laser Endomicroscopy (VLE) and Endoscopic Mucosal Resection (EMR) in Patients With Barrett's Dysplasia or Intramucosal Adenocarcinoma
Sponsor:
NinePoint Medical
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
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:
Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its development is mostly associated with chronic injury from gastroesophageal reflux. BE is widely considered the leading risk factor for the development of esophageal adenocarcinoma (EAC).
Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to ultrasound, however, instead of producing an image from the scattering of sound waves, it utilizes optical scattering based on differences in tissue composition to form a two-dimensional image. The benefit of VLE over ultrasound is that it is capable of generating cross-sectional images of tissues with an axial-resolution of up to 10 micrometers, which is comparable to low-power microscopy.
The proposed trial will evaluate the ability of physicians to use VLE to visualize high grade intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the ex-vivo and in-vivo setting and correlate those images to standard histology of endoscopic mucosal resection specimens as the gold standard.
Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to ultrasound, however, instead of producing an image from the scattering of sound waves, it utilizes optical scattering based on differences in tissue composition to form a two-dimensional image. The benefit of VLE over ultrasound is that it is capable of generating cross-sectional images of tissues with an axial-resolution of up to 10 micrometers, which is comparable to low-power microscopy.
The proposed trial will evaluate the ability of physicians to use VLE to visualize high grade intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the ex-vivo and in-vivo setting and correlate those images to standard histology of endoscopic mucosal resection specimens as the gold standard.
Detailed Description:
The diagnosis of dysplasia and early adenocarcinoma in BE remains challenging. At present, endoscopy with biopsy of suspected BE lesions is the only available method. However, the endoscopic recognition of early dysplasia in BE relies on the subjective visual recognition by an endoscopist. The subtle mucosal variations and early dysplastic changes in the esophagus may easily be missed. The development of a wide-field, high resolution endoscopic microscopy could enhance the early detection and treatment of dysplasia in BE.
Study Oversight
Has Oversight DMC:
False
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?: