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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230022 / PAS001 |
| Date Original Protocol Accepted |
08/20/2025
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| Date Current Protocol Accepted |
11/19/2025
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| Study Name |
Jewel P-WCD Post-Approval Study
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| Device Name |
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel"), Jewel P-WCD Firmware, Device Accessories Skin Preparation Kit, Placement Accessory, Device Removal Kit, Optional Software Accessories ES Mobile Application, ES Cloud, ES Report Generator, ES Clinical Portal
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| Clinical Trial Number(s) |
NCT05201495
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
Historical Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This will be a prospective cohort study to demonstrate the continued safety and clinical effectiveness of the Jewel P-WCD. The study will also demonstrate the generalizability of the arrhythmia detection algorithm which was developed using techniques of artificial intelligence and machine learning (AI/ML). The study is also described by the sponsor as being an observational registry study.
All Jewel P-WCDs will be collected by the Sponsor following the end of the prescription period or device use, per commercial process. Devices which cannot be retrieved per commercial process will be considered lost to follow up.
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| Study Population |
All patients who are prescribed and receive a Jewel P-WCD device.
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| Sample Size |
Number of subjects: 6,330 to capture 100 shockable VT/VF events.
Assumptions for sample size estimation: It is assumed that the event rate will be similar to the KESTRA ACE PAS (Kestra Medical Technologies) which was 1.58%.
Number of sites: N/A
Sites location: N/A
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| Key Study Endpoints |
Safety Endpoints
Primary: The primary safety endpoint is to observe an inappropriate shock rate of no more than 2.0 inappropriate shocks per 100 patient-months using a one sided upper 90% confidence interval. Only first inappropriate shocks during analyzable wear time will contribute to the analysis of this endpoint. The appropriateness of shocks will be determined by the patient’s medical team.
Secondary: The secondary endpoints (report only) for this study are to observe: the proportion of subjects experiencing skin related Adverse Device Effects classified as MDR reportable; and, the number of subjects who deferred a shock and percentage of events successfully deferred.
Effectiveness Endpoints
Primary: The primary effectiveness endpoint is to demonstrate an overall detection rate greater than 87%, using a 90% one-sided lower confidence limit.
Secondary: N/A
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| Follow-up Visits and Length of Follow-up |
this is a registry and has no investigational device or intervention. Data will be analyzed after the completion of the prescribed wear period.
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