Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04984447
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-13
First Post:
2020-08-11
Brief Title:
OCT Guided Trans Nasal Imaging of the Small Intestine in Adults
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
OCT Guided Trans Nasal Imaging of the Small Intestine in Adults
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:
The investigators are seeking healthy adult volunteers 18-60 years and healthy pregnant women in their 2nd trimester of pregnancy for a research study to assess a new imaging device The Tearney Laboratory at the Wellman Center for Photomedicine at Massachusetts General Hospital is developing high-resolution imaging devices that can be used to improve diagnostics in gastrointestinal diseases
Detailed Description:
The investigators have developed a device that can image the duodenum the first part of the small intestine The device consists of a thin flexible tube with a small internal camera inside of it that takes high-resolution images of the gastrointestinal tract The device will be introduced through the nose and then advanced into the stomach and duodenum Participant tolerability imaging quality and the optimal imaging technique will be evaluated The results of this study will be used as the basis for a larger study to be conducted at the Aga Khan University Hospital in Pakistan where subjects with suspected or diagnosed EED will be imaged
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