Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success Study

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Tulavi Therapeutics,Inc.
Study ID
NCT07246980
Status
Recruiting
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Conditions

  • Peripheral Nerve Injuries

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nerve Cap — DEVICE
    Patients who have or will receive allay Hydrogel Cap

Study Details

is is a multi-center, open-label, observational registry study (both prospective and retrospective) designed to evaluate the safety and performance of the allay™ Hydrogel Cap. This cap is an in situ forming implantable hydrogel medical device used in various peripheral nerve surgeries, including amputation and neuroma excision. 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.

Key Dates

Start date
May 6, 2026
Status verified
Jun 2026
Primary completion
Jan 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Assessment of change in Pain Scores from baseline using VAS [ Time Frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery) ]

Locations (2)

FacilityCityStateZIP
Florida Orthopedic InstituteSt. PetersburgFlorida33702
Complete Foot and Ankle Care of North Texas, PADentonTexas33702

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Florida Orthopedic Institute· St. Petersburg, FLComplete Foot and Ankle Care of North Texas, PA· Denton, TX

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