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Jewel P-WCD Post-Approval Study (PAS)

Jewel P-WCD Post-Approval Study (PAS)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07256678
Enrollment
6330
Registered
2025-12-01
Start date
2026-01-31
Completion date
2029-12-31
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jewel-P WCD

Brief summary

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

Detailed description

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

Interventions

OTHERThis 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

OTHERJewel

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

Sponsors

Element Science, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percent of VT/VF events successfully detected by the Jewel P-WCDFrom enrollment to the end of treatment at approximately 90 days

Contacts

Primary ContactVP, Regulatory Affairs and Quality
vis@elementsci.com408-212-1516

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026