Integra Neurogen 3D Matrix Device (Nerve Injury) - Clinical Trial

What is the Purpose of this Study?


We are doing this study to find out if an investigational product called the NeuraGen 3D Nerve Guide Matrix can improve healing and recovery from traumatic nerve injuries.

What is the Condition Being Studied?

Traumatic Nerve Injury of the Hand

Who Can Participate in the Study?

Key Eligibility

Adults ages 18-65 who:
- Have a digital nerve injury of their hand that their ability to use it
- Have not had any previous surgery to repair the affected nerve in their hand
- Do not have an infection around the damaged nerve in their hand
- Are not pregnant

For more information about who can join this study, please contact the study team at

Age Group

What is Involved?


If you choose to join this study, you will have nerve repair surgery using the NeuraGen 3D Nerve Guide Matrix and have follow-up visits.

During these follow-up visits, you will:
- Visit our clinic 15 days, 30 days, 3 months, 6 months, 9 months, and 12 months after your surgery (6 visits)
- Have pain and wound assessments
- Answer questionnaires about your injury
- Have tests done on your grip strength and sensory sensitivity of the hand

Study Details

Full Title
An Open-Label, Multicenter, Pilot Study to Evaluate the Performance and Safety of NeuraGen® 3D Nerve Guide Matrix.
Principal Investigator
Protocol Number
IRB: PRO00105103
NCT: NCT05343143
Phase IV
Enrollment Status
Open for Enrollment