Peripheral Nerve InjuriesCOMPASSNCT07246980
Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success Study
An observational study of Peripheral Nerve Injuries, run by Tulavi Therapeutics,Inc. at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- Nerve Cap
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 May 2026to 1 May 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who received or will be receiving allay™ Hydrogel Cap at a participating study site are eligible for enrollment.
Who may be able to join
- Patients who have or will receive allay™ Hydrogel Cap
Who cannot join
- Patients who have not received allay™ Hydrogel Cap
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Complete Foot and Ankle Care of North Texas, PA
Denton, Texas, 33702
Damien Dauphinee, DPM, 972-896-9611, dmdsurgery@gmail.com
Siobhan Cemper, (940) 300-3054 ext. 2014, scemper@completefootandanklcare.com
- Recruiting
University of Colorado Anschutz.
Englewood, Colorado, 80112
Layla Haji, 720-872-4850, layla.haji@ucdenver.edu
Tanner Bloks, Tanner.bloks@cuanschutz.edu
- Recruiting
Orlando Health
Orlando, Florida, 32806
Nicollete Clouser, 321-843-5687, nicollete.clouser@orlandohealth.com
Dr. Karan Desai
- Recruiting
Kaiser Permanente
Redwood City, California, 94063
Nancy Mendelssohn, 6504503459, Nancy.D.Mendelssohn@kp.org
Dr. Edward Kobraie
- Recruiting
Florida Orthopedic Institute
St. Petersburg, Florida, 33702
Dr. Dzi-Viet Nguyen, DO, (727) 527-5272, dnguyen@floridaortho.com
katie Foss, 727-369-4994, kfoss@floridaortho.com
About this study
Official title: Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success (COMPASS) Study: An Open Label Registry Study to Assess the Safety and Performance of the Allay™ Hydrogel Cap
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.
Read more
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.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- Nerve Cap
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve CapDevice
Patients who have or will receive allay Hydrogel Cap
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in Pain Scores from baseline using VAS
Pain scores will be collected using either of the following scales:
- 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
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.
Measured: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 months (Post Surgery)
Secondary outcomes (1)
Incidence of Device Failures surgical & medical complications, unplanned re-operations, and unexpected adverse device events (UADEs)
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.
Measured: Upto 2 years Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start6 May 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Tulavi Therapeutics,Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246980
- Sponsor's protocol ID
- CLP-0002
- Acronym
- COMPASS
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success (COMPASS) Study: An Open Label Registry Study to Assess the Safety and Performance of the Allay™ Hydrogel Cap
- ClinicalTrials.gov ID
- NCT07246980
- Acronym / sponsor ID
- COMPASS / CLP-0002
- Conditions
- Peripheral Nerve Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tulavi Therapeutics,Inc.Industry (pharma, biotech, devices)
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who received or will be receiving allay™ Hydrogel Cap at a participating study site are eligible for enrollment.
Key inclusion criteria (1 listed)
- Patients who have or will receive allay™ Hydrogel Cap
Key exclusion criteria (1 listed)
- Patients who have not received allay™ Hydrogel Cap
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve CapPatients who have or will receive allay Hydrogel Cap | Device | – |
Primary outcome
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)
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.
Assessment of change in Pain scores from baseline using Numerical Rating Scale
Time frame: 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.
Assessment of change in Pain Interference from baseline using PROMIS PI Short Form 5b
Time frame: 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.
Assessment of change in Neuropathic Pain Quality from baseline using Patient-Reported Outcome Measurement Information System (PROMIS) v2.0 Neuropathic Pain Quality 5a
Time frame: 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.
Assessment of change in Cold Intolerance from baseline using Cold Intolerance Symptom Severity (CISS) score
Time frame: 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.
Assessment of change from baseline in the average quantity of pain medication taken via the Medication Quantification Scale (MQS) at 12 months.
Time frame: 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.
1 secondary outcome
Incidence of Device Failures surgical & medical complications, unplanned re-operations, and unexpected adverse device events (UADEs)
Time frame: Upto 2 years Post Surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injuries, run by Tulavi Therapeutics,Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.