Ignite Creation Date:
2024-05-06 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03566160
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2018-05-25
Brief Title:
Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy
Status:
ACTIVE_NOT_RECRUITING
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:
Environmental enteric dysfunction EED is a poorly understood condition characterized by intestinal inflammation and loss of barrier function that is prevalent in regions of the world with inadequate sanitation and hygiene EED is a major driver of malnourishment poor neurological development stunting oral vaccine failure and infection affecting 25 of all children globally and causing over a million deaths each year
Progress towards understanding EED and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic In order to prevent the deleterious and permanent sequelae of the disease there is a need for effective diagnosis and intervention to be implemented in EED patients before the age of 2 Currently the only means for directly evaluating the intestine is endoscopy with mucosal biopsy Unfortunately endoscopy is untenable for the study of EED because of limited resources and the high cost As a result there is a clear unmet need for a less invasive tool that can be used in low-and-middle-income-countries LMICs to evaluate the intestine in population with EED
This work is supported by a grant from The Bill and Melinda Gates Foundation BMGF The overall goal is to provide a minimally invasive means of obtaining detailed infantile intestinal tissue information that is needed for the development of effective EED interventions Obtaining biopsies will play a critical role in gathering the detailed intestinal tissue information
The purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to obtain biopsies in adults
Progress towards understanding EED and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic In order to prevent the deleterious and permanent sequelae of the disease there is a need for effective diagnosis and intervention to be implemented in EED patients before the age of 2 Currently the only means for directly evaluating the intestine is endoscopy with mucosal biopsy Unfortunately endoscopy is untenable for the study of EED because of limited resources and the high cost As a result there is a clear unmet need for a less invasive tool that can be used in low-and-middle-income-countries LMICs to evaluate the intestine in population with EED
This work is supported by a grant from The Bill and Melinda Gates Foundation BMGF The overall goal is to provide a minimally invasive means of obtaining detailed infantile intestinal tissue information that is needed for the development of effective EED interventions Obtaining biopsies will play a critical role in gathering the detailed intestinal tissue information
The purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to obtain biopsies in adults
Detailed Description:
This study will test the capacity of a gastrointestinal tract cryobiopsy probe that Tearney Lab investigators have designed to obtain biopsies from the upper GI tract
A total of twenty 20 subjects adults 18 years of age and older scheduled for elective esophagogastroduodenoscopy with biopsy will be enrolled in this study
A maximum of 3 cryobiopsies per subject will be collected After each cryobiopsy is complete the endoscopist will then take 1 standard forceps biopsy from the area adjacent to where cryobiopsy was performed A maximum of 3 standard forceps biopsies for research purposes only will be taken Biopsy collection will be performed at the discretion of the endoscopist The standard forceps biopsy sites will also be monitored directly throughout the entire experimental procedure The total experimental procedure time will not exceed 15 minutes
A total of twenty 20 subjects adults 18 years of age and older scheduled for elective esophagogastroduodenoscopy with biopsy will be enrolled in this study
A maximum of 3 cryobiopsies per subject will be collected After each cryobiopsy is complete the endoscopist will then take 1 standard forceps biopsy from the area adjacent to where cryobiopsy was performed A maximum of 3 standard forceps biopsies for research purposes only will be taken Biopsy collection will be performed at the discretion of the endoscopist The standard forceps biopsy sites will also be monitored directly throughout the entire experimental procedure The total experimental procedure time will not exceed 15 minutes
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?:
False
Is an FDA AA801 Violation?:
None