← Back to Search

Procedure

Axoguard Nerve Protector for Cubital Tunnel Syndrome (COVERED Trial)

N/A

Recruiting

Research Sponsored by Axogen Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be eligible for surgical intervention;

Have a preoperative diagnostic such as a nerve conduction study, electromyography, or ultrasound evaluation documenting ulnar neuropathy at the elbow;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-18 months

Awards & highlights

COVERED Trial Summary

This trial will test how well Axoguard HA+ Nerve Protector can protect a nerve during a cubital tunnel operation. It'll measure pain, motor/sensory outcomes, QoL, & more to see if it's successful.

Who is the study for?

This trial is for adults over 18 who've had previous cubital tunnel decompression surgery but still experience symptoms like pain, numbness, or muscle weakness in the hand. They must have documented ulnar nerve issues at the elbow and be ready for a first revision surgery where Axoguard HA+ Nerve Protector will be used.Check my eligibility

What is being tested?

The study is testing Axoguard HA+ Nerve Protector's effectiveness in protecting the ulnar nerve during a first revision of cubital tunnel decompression surgery. It aims to assess pain relief, motor and sensory function improvement, quality of life enhancement, and whether it prevents further surgeries.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include typical surgical complications such as infection, bleeding, or adverse reactions to the implant material used to protect the nerve.

COVERED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible for surgery.

Select...

I have had a test confirming elbow nerve damage.

Select...

I have weakness or muscle loss in my hand.

Select...

I am having my first surgery to fix cubital tunnel syndrome with a specific nerve protector.

Select...

I feel numbness or tingling in my pinky and ring fingers.

Select...

My elbow pain from ulnar nerve issues scores at least 40 out of 100.

Select...

I am 18 years old or older.

COVERED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual analog scale (VAS)

Secondary outcome measures

12-Item Short Form Health Survey (SF-12)

Grip strength

Modified McGowan classification

+5 more

Other outcome measures

Proportion of participants with healthy ulnar nerve appearance

COVERED Trial Design

1Treatment groups

Experimental Treatment

Group I: First Revision Cubital Tunnel with application of Axoguard HA+ Nerve ProtectorExperimental Treatment1 Intervention

Single group assignment. Patients will receive the Axoguard HA+ Nerve Protector™ in their first revision cubital tunnel surgery.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Axogen CorporationLead Sponsor

10 Previous Clinical Trials

5,568 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been included in the experiment thus far?

"Affirmative. According to clinicaltrials.gov, this trial initially went live on October 19th 2023 and was last revised on November 2nd of the same year. As of now, they are in need of up to 20 volunteers from 1 site."

Answered by AI

Does the research team currently have openings for participants?

"Affirmative. The research displayed on clinicaltrials.gov reveals that the trial is actively enrolling participants, having first been posted on October 19th 2023 and recently updated November 2nd of the same year. With a total search for 20 individuals across 1 medical centre, this study promises to be an interesting one!"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression

2023. "Nerve Protection Evaluation: Revision Cubital Tunnel Syndrome Decompression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06117501.

All > Vision