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Nerve Guide Matrix

NeuraGen 3D for Digital Nerve Injury

N/A
Waitlist Available
Research Sponsored by Integra LifeSciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has one, single level, digital nerve injury that involves complete traumatic nerve section of the common or proper nerve of the palmar aspect of hand
Subject has adequate vascular perfusion of the target hand as assessed by the investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial looks at the safety and performance of a medical product over a year with 10 participants.

Who is the study for?
This trial is for individuals who have recently (within 21 days) suffered a complete traumatic cut of specific nerves in the palm. They must be able to close the nerve gap without too much tension using the device, have good blood flow in their hand, and can keep their injured hand still after surgery. The other hand should be fully functional.Check my eligibility
What is being tested?
The study is testing NeuraGen 3D Nerve Guide Matrix on people with digital nerve injuries. It's an initial look at how well it works and its safety over a year with ten participants across multiple centers, without comparing it to another treatment.See study design
What are the potential side effects?
Since this summary doesn't provide specific side effects of NeuraGen 3D Nerve Guide Matrix, we can assume general risks may include infection, pain at the injury site, inflammation or allergic reactions related to implant materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a single, completely cut nerve injury in my hand.
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My hand's blood flow is good, as checked by my doctor.
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My other hand is fully functional and healthy.
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I can keep my injured hand still after surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
The primary objective of this study is to evaluate return to sensory recovery with the NeuraGen 3D Nerve Guide Matrix in a small group of subjects with primary nerve injury of the hand.(s2PD) at each post-operative timepoint of the study.
Secondary outcome measures
Continuous Visual Analog Scale for Pain at each post-operative timepoint of the study
Disabilities of the Arm, Shoulder and Hand (DASH) Score at each post-operative timepoint of the study
Grip Strength Test at each post-operative timepoint of the study
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: NeuraGen 3D Nerve Guide MatrixExperimental Treatment1 Intervention
Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.

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Who is running the clinical trial?

Integra LifeSciences CorporationLead Sponsor
84 Previous Clinical Trials
9,479 Total Patients Enrolled
Maria LeonardStudy DirectorIntegra LifeSciences

Media Library

NeuraGen 3D Nerve Guide Matrix (Nerve Guide Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT05343143 — N/A
Digital Nerve Injury Research Study Groups: NeuraGen 3D Nerve Guide Matrix
Digital Nerve Injury Clinical Trial 2023: NeuraGen 3D Nerve Guide Matrix Highlights & Side Effects. Trial Name: NCT05343143 — N/A
NeuraGen 3D Nerve Guide Matrix (Nerve Guide Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05343143 — N/A

Frequently Asked Questions

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

Are there any current openings for participation in this research?

"Affirmative. Clinicaltrials.gov provides evidence that this investigation, which was first made available on May 15th 2022, is still recruiting patients. Approximately 10 volunteers need to be sourced from 3 different medical institutions."

Answered by AI

To what degree has recruitment progressed for this research endeavor?

"Affirmative. The information uploaded onto clinicaltrials.gov reveals that this research endeavour, which was first published on May 15th 2022, is actively looking for participants. Approximately 10 individuals need to be recruited from 3 different medical facilities."

Answered by AI

Is the enrollment protocol of this experiment limited to individuals below a certain age?

"The patient population for this clinical trial consists of individuals aged 18 years and above but below 65 years old."

Answered by AI

What eligibility criteria are necessary for participation in this research?

"This experiment is welcoming 10 individuals between 18 and 65 who have suffered nerve damage in their hands. For inclusion, an additional criteria must be met: a total cut of the common or proper digital nerve along the palm side of the hand must exist while its opposite has normal functionality."

Answered by AI

What are the key aims of this medical experiment?

"The primary endpoint assessed over the course of the 12 month trial is a descriptive analysis of Static 2 Point Discrimination Test (s2PD). Additionally, Continuous Visual Analog Scale for Pain at each post-operative timepoint and Moving 2 Point Discrimination Test (m2PD) as well as Grip Strength Test will be analysed. These latter metrics shall be completed in office visits using DeMayo's two point discrimination device or Camry hand dynamometer respectively."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
NeuraGen 3D Pilot Study
2022. "NeuraGen 3D Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05343143.
~3 spots leftby Apr 2025
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