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Doorlopend Observationeel Monitoringprogramma voor Allay™ Hydrogel Cap Veiligheids- en Successtudie (COMPASS)

17 september 2026 bijgewerkt door: Tulavi Therapeutics,Inc.

Doorlopend Observationeel Monitoringsprogramma voor Veiligheid en Succes van Allay™ Hydrogel Cap (COMPASS) Studie: Een Open Label Registerstudie om de Veiligheid en Prestatie van de Allay™ Hydrogel Cap te Beoordelen

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

1000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Redwood City, California, Verenigde Staten, 94063
        • Werving
        • Kaiser Permanente
        • Contact:
        • Hoofdonderzoeker:
          • Dr. Edward Kobraie
    • Colorado
      • Englewood, Colorado, Verenigde Staten, 80112
    • Florida
      • Orlando, Florida, Verenigde Staten, 32806
      • St. Petersburg, Florida, Verenigde Staten, 33702
        • Werving
        • Florida Orthopedic Institute
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Dzi-Viet Nguyen, DO
    • Texas
      • Denton, Texas, Verenigde Staten, 33702
        • Werving
        • Complete Foot and Ankle Care of North Texas, PA
        • Hoofdonderzoeker:
          • Damien Dauphinee, DPM
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

All patients who received or will be receiving allay™ Hydrogel Cap at a participating study site are eligible for enrollment.

Beschrijving

Inclusion Criteria:

  • Patients who have or will receive allay™ Hydrogel Cap

Exclusion Criteria:

  • Patients who have not received allay™ Hydrogel Cap

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: CASE_ONLY
  • Tijdsperspectieven: OTHER

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assessment of change in Pain Scores from baseline using VAS
Tijdsspanne: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)

Pain scores will be collected using either of the following scales:

1) The Visual Analog Scale (VAS) or 2) The Numerical Rating Scale (NRS)

The VAS for pain is a simple, validated tool used to measure a patient's perceived pain intensity. It consists of a straight 100 mm horizontal line labeled from "no pain" (0) on the left to "worst imaginable pain" (100) on the right. Patients are asked to mark a point on the line that corresponds to their current level of pain, which is then measured in millimeters from the zero point to quantify the score. The VAS is widely used in both clinical and research settings due to its ease of use and sensitivity to changes in pain over time.
Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)
Assessment of change in Pain scores from baseline using Numerical Rating Scale
Tijdsspanne: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)

The NRS is a validated pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable. The patient selects the single whole number that best reflects how severe their current pain is to them.
Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)
Assessment of change in Pain Interference from baseline using PROMIS PI Short Form 5b
Tijdsspanne: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)

The Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) scale is a validated tool used to assess the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It measures the impact of pain over the past seven days using a series of standardized questions rated on a 5-point Likert scale. Scores are converted to T-scores, with higher scores indicating greater pain interference. The PROMIS-PI is widely used in clinical research due to its reliability, responsiveness, and ability to compare results across diverse patient populations.
Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)
Assessment of change in Neuropathic Pain Quality from baseline using Patient-Reported Outcome Measurement Information System (PROMIS) v2.0 Neuropathic Pain Quality 5a
Tijdsspanne: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)

The Patient-Reported Outcome Measurement Information System (PROMIS) v2.0 Neuropathic Pain Quality 5a is a 5-item, self-administered questionnaire for participants to assess qualities of neuropathic pain, like "numb," "tingly," and "shooting," over the past seven(7) days. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores indicate more severe neuropathic pain. It helps to accurately screen for neuropathic pain, which arises from nerve damage, versus nociceptive pain, which comes from tissue injury, and can then assess the severity of the condition.
Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)
Assessment of change in Cold Intolerance from baseline using Cold Intolerance Symptom Severity (CISS) score
Tijdsspanne: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)

The Cold Intolerance Symptom Severity (CISS) score is a validated patient-reported outcome measure used to assess the severity of cold intolerance, often following peripheral nerve injury or extremity trauma. The questionnaire includes six items evaluating symptoms such as pain, numbness, stiffness, color changes, and the impact on daily activities in response to cold exposure. Each item is scored on a Likert scale, with the total score ranging from 4 to 100, where higher scores indicate greater symptom severity. The CISS is commonly used in clinical research to quantify cold intolerance and monitor changes over time or in response to interventions.
Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)
Assessment of change from baseline in the average quantity of pain medication taken via the Medication Quantification Scale (MQS) at 12 months.
Tijdsspanne: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 months (Post Surgery)

A pain medication log will be provided to each participant to complete at all visits.

For opioid and non-opioid pain medications, the Medication Quantification Scale (MQS) Version III is a validated tool used to quantify the complexity and detriment of pain medication regimens. It calculates a single numeric value by combining medication detriment weights (ranging from 1.1 to 4.5) with dosage levels (scaled from 1 for subtherapeutic use to 4 for supratherapeutic use). A higher MQS score indicates greater potential medication detriment and/or dosage intensity. At 12 months, the study assessed changes from baseline in patients' average MQS scores.
Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 months (Post Surgery)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Device Failures surgical & medical complications, unplanned re-operations, and unexpected adverse device events (UADEs)
Tijdsspanne: Upto 2 years Post Surgery

Secondary endpoints of the study include safety assessment based on the incidence of device failures, surgical & medical complications, unplanned re-operations, and unexpected adverse device events (UADEs) in the study population.
Upto 2 years Post Surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tulavi Therapeutics,Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 mei 2026

Primaire voltooiing (Geschat)

1 januari 2029

Studie voltooiing (Geschat)

1 mei 2029

Studieregistratiedata

Eerst ingediend

13 november 2025

Eerst ingediend dat voldeed aan de QC-criteria

21 november 2025

Eerst geplaatst (Werkelijk)

24 november 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 september 2026

Laatste update ingediend die voldeed aan QC-criteria

17 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLP-0002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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