Axoguard HA+ for Head and Neck Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Axoguard HA+ Nerve Protector for individuals with head and neck cancers undergoing surgery. The main goal is to determine if wrapping a nerve in the shoulder with this treatment during surgery improves shoulder function after one year. Individuals who have not received previous treatments for their head or neck cancer and are undergoing specific types of neck surgery may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially enhance future treatment options.
What prior data suggests that the Axoguard HA+ Nerve Protector is safe for patients with head and neck cancers?
Research has shown that the Axoguard HA+ Nerve Protector is usually well-tolerated in surgeries. Studies have found it helps protect nerves and aids in healing. However, some people report side effects like nausea and pain. These side effects are common in medical treatments and can usually be managed. Discuss any concerns with your doctor to determine if this trial might be suitable for you.12345
Why are researchers excited about this trial?
Axoguard HA Plus Nerve Protector is unique because it focuses on protecting and repairing nerves affected by head and neck cancers, which is not the primary focus of traditional treatments like surgery, radiation, and chemotherapy. Unlike these standard treatments that aim to remove or destroy cancer cells, Axoguard HA Plus uses a specialized nerve protector that may help preserve nerve function and improve recovery outcomes. Researchers are excited about this treatment because it offers a novel approach that could potentially enhance quality of life for patients by reducing side effects associated with nerve damage.
What evidence suggests that the Axoguard HA+ Nerve Protector is effective for improving shoulder function in head and neck cancer patients?
Research shows that the Axoguard HA+ Nerve Protector can improve nerve healing and reduce post-surgery complications. In previous studies, surgeons wrapped it around nerves to prevent scar tissue, allowing smoother nerve movement. This may result in less pain and improved mobility. Early results suggest that patients experienced fewer shoulder issues after using Axoguard HA+ during surgery. In this trial, participants will receive the Axoguard HA+ treatment, designed to protect nerves and potentially improve outcomes for those undergoing neck surgery.12346
Who Is on the Research Team?
Daniel Zandberg
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for patients with head and neck cancers who are scheduled to undergo neck dissection surgery. The study aims to include those who can be assessed for shoulder function about a year after their operation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Patients undergo neck dissection and the spinal accessory nerve is wrapped with the Axoguard HA+ Nerve Protector
Post-operative Assessment
The presence and severity of neck and shoulder dysfunction are assessed approximately twelve months post-operatively
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Axoguard HA Plus Nerve Protector
Trial Overview
The intervention being tested is the use of Axoguard HA+ Nerve Protector during surgery, which involves wrapping the nerve that goes to the shoulder in hopes of improving post-operative shoulder function.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Matthew Spector
Lead Sponsor
Axogen Corporation
Industry Sponsor
Citations
Axoguard HA Plus Nerve Protector to Reduce Post ...
In this prospective study, patients with head and neck cancers undergoing neck dissection will have the nerve to the shoulder wrapped with the ...
Axoguard HA+ Nerve Protector
Learn about Axoguard HA+ Nerve Protector® and see how surgeons are using it for enhanced nerve gliding and minimizariun of soft tissue attachments.
Case Overview: Axoguard HA+ Nerve Protector®
Matthew Wilson, MD, shares his experience with Axoguard HA+ Nerve Protector®. A patient presented with significant pain and paresthesia ...
axgn-20231231 - Investor Relations - axogen
We have applied the average sales price of the Avance Nerve Graft, Axoguard Nerve Connector, and Axoguard Nerve Protector that address such PNI ...
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accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=19582190&pc=JXIMAUDE Adverse Event Report: AXOGEN CORPORATION ...
MAUDE Adverse Event Report: AXOGEN CORPORATION AXOGUARD HA+ NERVE PROTECTOR; NERVE CUFF ; Patient Problems Nausea (1970); Pain (1994) ; Event Date ...
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accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20668018&pc=JXIMAUDE Adverse Event Report: AXOGEN CORPORATION ...
The issue arose after the removal of the skin stitches, leading to the dehiscence of the proximal incision, which ultimately required the axoguard ha+ nerve ...
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