NCT05201495

The Jewel IDE Study

A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Element Science, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sudden Cardiac Arrest

Interventions

Type	Name	Description
DEVICE	Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)	Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.

Timeline

• Start date: 2022-01-12
• Primary completion: 2023-11-10
• Completion: 2023-11-10
• First posted: 2022-01-21
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated device study