Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-06 @ 10:40 PM
Study NCT ID:
NCT03066895
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2017-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BGS Neonatal Pilot Study
Sponsor:
Actuated Medical, Inc.
Organization:
Study Overview
Official Title:
Development and Testing of BabyGentleStick⢠Vibrated Needle System for Heel Lance- Neonatal Pilot Study
Status:
COMPLETED
Status Verified Date:
2020-09
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:
This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStickâ˘; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: