Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-28 @ 11:16 AM
Study NCT ID:
NCT03610958
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2018-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
Sponsor:
Epitomee medical
Organization:
Study Overview
Official Title:
Prospective, Single Center, Open-labeled Single Arm Study, to Asses the Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss in Healthy Over Weight and Obese Subjects
Status:
COMPLETED
Status Verified Date:
2021-08
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:
Study design to demonstrate the safety and performance of the Epitomee Device
Detailed Description:
Prospective, single center, open-labeled single arm study. The subjects will be enrolled in one investigational site. Subjects meeting eligibility criteria will receive multiple capsule intakes, 1 capsule twice daily for 12 weeks.
Study Oversight
Has Oversight DMC:
True
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?: