Jewel P-WCD Post-Approval Study (PAS)

NCT ID: NCT07256678

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

6330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Jewel-P WCD

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type OTHER

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

Jewel

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Jewel

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Element Science, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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VP, Regulatory Affairs and Quality

Role: CONTACT

408-212-1516

Other Identifiers

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PR-3162

Identifier Type: -

Identifier Source: org_study_id

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