Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04565704
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-13
First Post:
2020-08-11
Brief Title:
Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system
Detailed Description:
The investigators have previously developed optical imaging systems that have been able to provide highly detailed images of tissue structures in multiple application areas including Cardiology Gastroenterology and Pulmonology They are looking to continue the advancement of these various technologies under development
The population will include subjects who are undergoing elective esophagogastroduodenoscopy with biopsy colonoscopy with biopsy andor endo-mucosal resectionThe endoscopist will take no more than 3 biopsies in addition to the standard of care biopsies
The study will be optical imaging of the ex vivo GI specimens that are being collected Specimens will be collected for research purposes only Offline analysis of the samples will be performed and optical imaging findings will be correlated with the pathology findings This will require review of the medical record to link the findings of the imaging with the pertinent medical information Samples will be de-identified and subjects will be assigned a unique number The tissues will be placed in marked containers labeled for research purposes only The samples collected will be brought to the Tearney Research Laboratory for imaging and processing The Optical imaging of the tissue samples will not affect the standard of care procedure
The population will include subjects who are undergoing elective esophagogastroduodenoscopy with biopsy colonoscopy with biopsy andor endo-mucosal resectionThe endoscopist will take no more than 3 biopsies in addition to the standard of care biopsies
The study will be optical imaging of the ex vivo GI specimens that are being collected Specimens will be collected for research purposes only Offline analysis of the samples will be performed and optical imaging findings will be correlated with the pathology findings This will require review of the medical record to link the findings of the imaging with the pertinent medical information Samples will be de-identified and subjects will be assigned a unique number The tissues will be placed in marked containers labeled for research purposes only The samples collected will be brought to the Tearney Research Laboratory for imaging and processing The Optical imaging of the tissue samples will not affect the standard of care procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None