MedTrace Logo

The Jewel IDE Study

NCT05201495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2026-04-27

Study results available
· View outcomes & findings →

Summary

The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL")

Conditions

  • Sudden Cardiac Arrest

Interventions

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.

Sponsors & Collaborators

  • Element Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Javed Butler, M.D. · University of Mississippi Medical Center

  • John Hummel, M.D. · Ohio State University

  • Roxana Mehran, M.D. · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-12
Primary Completion
2023-11-10
Completion
2023-11-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05201495 on ClinicalTrials.gov