NCT07246980 Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success Study
| NCT ID | NCT07246980 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulavi Therapeutics,Inc. |
| Condition | Peripheral Nerve Injuries |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-05-06 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients who have or will receive allay™ Hydrogel Cap Exclusion Criteria: * Patients who have not received allay™ Hydrogel Cap
Frequently Asked Questions
Who can join the NCT07246980 clinical trial?
This trial is open to participants of all sexes, studying Peripheral Nerve Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07246980 currently recruiting?
Yes, NCT07246980 is actively recruiting participants. Visit ClinicalTrials.gov or contact Tulavi Therapeutics,Inc. to inquire about joining.
Where is the NCT07246980 trial being conducted?
This trial is being conducted at Redwood City, United States, Englewood, United States, Orlando, United States, St. Petersburg, United States and 1 additional location.
Who is sponsoring the NCT07246980 clinical trial?
NCT07246980 is sponsored by Tulavi Therapeutics,Inc.. The trial plans to enroll 1,000 participants.