Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success Study
NCT ID: NCT07246980
Last Updated: 2025-12-02
Study Results
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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NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2026-01-01
2029-05-01
Brief Summary
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The study aims to gather demographic, operative, and clinical outcomes data from patients who have received the device.
The primary endpoints focus on the device's clinical performance, assessed using patient-reported outcomes (PROs). These include tracking changes in pain scores, pain intolerance, and cold intolerance, as well as the incidence of neuroma recurrence and changes in pain medication use from baseline.
Secondary endpoints concentrate on safety, monitoring the incidence of device failures, surgical complications, unplanned re-operations, and unexpected adverse device events (UADEs) within the study population. Essentially, the registry is collecting real-world data to determine how well and how safely the allay™ cap performs in a clinical setting.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
OTHER
Interventions
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Nerve Cap
Patients who have or will receive allay Hydrogel Cap
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Tulavi Therapeutics,Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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CLP-0002
Identifier Type: -
Identifier Source: org_study_id
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