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NCT Number: NCT07256678

Jewel P-WCD Post-Approval Study (PAS)

The objective of this PAS is to demonstrate the continued safety and clinical effectiveness of the Jewel P-WCD.

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Key information

Conditions

Jewel-P WCD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Jewel

Other

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

VP, Regulatory Affairs and Quality

CONTACT

[email protected]

408-212-1516

Sponsors and collaborators

Lead sponsor

Element Science, Inc.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 1, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.