Jewel P-WCD Post-Approval Study (PAS)

November 20, 2025 updated by: Element Science, Inc.
The objective of this PAS is to demonstrate the continued safety and clinical effectiveness of the Jewel P-WCD.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an observational registry study of the Jewel P-WCD in post-market use

Study Type

Observational

Enrollment (Estimated)

6330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: VP, Regulatory Affairs and Quality
  • Phone Number: 408-212-1516
  • Email: vis@elementsci.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient population who are at elevated risk of Sudden Cardiac Arrest (SAC) while they wait for permanent diagnosis.

Description

Inclusion Criteria:

  • N/A - registry will collect data already obtained commercially from patients prescribed the Jewel P-WCD.

Exclusion Criteria:

  • N/A - registry will collect data already obtained through commercial consent from patients prescribed the Jewel P-WCD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
This study is an observational registry study of the Jewel P-WCD in post-market use
Other: This study is an observational registry study of the Jewel P-WCD in post-market use
This study is an observational registry study of the Jewel P-WCD in post-market use
Other: Jewel
This study is an observational registry study of the Jewel P-WCD in post-market use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of VT/VF events successfully detected by the Jewel P-WCD
Time Frame: From enrollment to the end of treatment at approximately 90 days
From enrollment to the end of treatment at approximately 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Element Science, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • PR-3162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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