Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04485936
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2018-07-09
Brief Title:
Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects
Sponsor:
Epitomee medical
Organization:
Epitomee medical
Study Overview
Official Title:
Prospective Single Center Open-labeled Single Arm Study of Evaluation of the Effect of Tulip Device on Gastric Emptying Rate in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2020-07
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:
Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects
Detailed Description:
The participants will be enrolled in one investigational site Subjects meeting eligibility criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment baseline
Following the scintigraphy the subjects will receive Tulip Device treatment - 2 capsulesday
After repeated capsule intake for either 4 or 11 or 28 days the subjects will undergo additional gastric emptying test with a capsule intake prior to the test meal
Following the scintigraphy the subjects will receive Tulip Device treatment - 2 capsulesday
After repeated capsule intake for either 4 or 11 or 28 days the subjects will undergo additional gastric emptying test with a capsule intake prior to the test meal
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