Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04296513
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2020-03-03
Brief Title:
Diagnosis of Gastritis H Pylori Infection and Atrophic Gastritis in Dyspeptic Patients
Sponsor:
Instituto Ecuatoriano de Enfermedades Digestivas
Organization:
Instituto Ecuatoriano de Enfermedades Digestivas
Study Overview
Official Title:
High-Definition White Light Endoscopy vs Optical Enhancement With High Definition Optical Magnification in the Diagnosis of Gastritis H Pylori Infection and Atrophic Gastritis in Dyspeptic Patients A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-02
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:
Gastric cancer is the third most common cause of cancer-related death worldwide 1 Upper endoscopy is necessary to detect neoplastic macroscopic features at an early stage but subtle abnormalities in the gastric mucosa are often missed or misdiagnosed 1 Helicobacter pylori Hp is involved in the pathogenesis of gastric diseases such as peptic ulcers gastric lymphoma and gastric cancer Therefore the necessity to recognize malignant gastric lesions at an early stage is imperative
Detailed Description:
Previous I-SCAN technology uses white light as illumination light and digital post-processing of the reflection afterwards creates images yielding the virtual chromoendoscopic image Emission of white light alone causes a potential limitation for the current I-SCAN technology to obtain high-quality images of microvascular patterns on the mucosal surface compared to narrow band imaging NBI with optical magnification
Pentax Medical HOYA Tokyo Japan developed the Optical Enhancement OE System which combines bandwidth-limited light with an endoscopy video system The OE System combines digital signal processing with optical filters that limit the spectral characteristics of the illuminating light connecting the peaks of the hemoglobin absorption spectrum 415 nm 540 nm and 570 nm to create a continuous wavelength spectrum This system has two modes that use different filters to optimize the visualization of specific features Mode 1 is designed to improve visualization of microvessels with enough light Mode 2 is designed to improve contrast of white-light observation by bringing the color tone of the overall image closer to that of natural color white color tone with more light than Mode 1 filter
In addition high definition optical magnification endoscopes have been developed and can combine high-definition imaging with optical magnification to produce detailed images with magnification of up to 136 This imaging technique facilitates the evaluation of the superficial vascular aspects of the mucosa enabling the identification of early signs of inflammation or lesions not previously seen with conventional endoscopy
Pentax Medical HOYA Tokyo Japan developed the Optical Enhancement OE System which combines bandwidth-limited light with an endoscopy video system The OE System combines digital signal processing with optical filters that limit the spectral characteristics of the illuminating light connecting the peaks of the hemoglobin absorption spectrum 415 nm 540 nm and 570 nm to create a continuous wavelength spectrum This system has two modes that use different filters to optimize the visualization of specific features Mode 1 is designed to improve visualization of microvessels with enough light Mode 2 is designed to improve contrast of white-light observation by bringing the color tone of the overall image closer to that of natural color white color tone with more light than Mode 1 filter
In addition high definition optical magnification endoscopes have been developed and can combine high-definition imaging with optical magnification to produce detailed images with magnification of up to 136 This imaging technique facilitates the evaluation of the superficial vascular aspects of the mucosa enabling the identification of early signs of inflammation or lesions not previously seen with conventional endoscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None