Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 6:04 PM
Study NCT ID:
NCT05201495
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Jewel IDE Study
Sponsor:
Element Science, Inc.
Organization:
Study Overview
Official Title:
A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL")
Detailed Description:
Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in patients at high risk for Sudden Cardiac Arrest
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?:
None
Is an FDA AA801 Violation?: