Trials Sponsors Conditions Drugs Pricing

Conditions

Amputation Chronic Nerve Pain Symptomatic Neuroma

Keywords

Peripheral Nerve InjuriesPeripheral Nervous System DiseaseNeuromaNerve PainNervous System DiseasesTrauma - Nervous SystemAmputationNerve RepairSurgical Treatment of Pain

Outcome Measures

Primary Outcomes (1)

Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs)
The primary safety endpoint will monitor the nature and incidence of AE's, SAE's and/or UADE's associated with an unplanned revision procedure prior to the planned Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) starting from implantation (operative day) through 15 months depending on whether or not the subject undergoes the secondary TMR or RPNI procedure.
15 Months

Secondary Outcomes (7)

Change in Visual Analog Scale (VAS) For Pain Score through TMR procedure or 12 post-operative months compared to baseline
Week 2, 1, 3, 6, 9 and 12 months
Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through TMR or RPNI procedure or 12 post operative months compared to baseline

Study Arms (1)

Axoguard Nerve Cap®

EXPERIMENTAL

Active Comparator: Porcine derived extracellular matrix (ECM) based Nerve Termination Device Implantation of appropriate diameter of Axoguard Nerve Cap® (sizes 5-7 mm) at the time of surgery

Device: Axoguard Nerve Cap®

Interventions

Axoguard Nerve Cap®Device

Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma

Axoguard Nerve Cap®

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Sign and date an IRB-approved written Informed Consent Form prior to initiation of any study procedures;
Be an adult male or female ≥ 18 and ≤ 80 years of age;

Sponsors & Collaborators

Axogen Corporation
Industrylead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Texas Tech University, Health Science Center

Lubbock, Texas, 79430, United States

MeSH Terms

Conditions

Peripheral Nerve InjuriesPeripheral Nervous System DiseasesNeuromaNeuralgiaNervous System DiseasesTrauma, Nervous System

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesWounds and InjuriesNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 29, 2021

Study Start

March 2, 2022

Actual (reported)

Primary Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Axoguard Nerve Cap®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Other Outcomes (2)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Axoguard Nerve Cap®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Other Outcomes (2)

You may not qualify if:

Data Sharing

Source record

Locations