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.
Who Can Participate?
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 jennifer.gallagher@duke.edu.
- 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 jennifer.gallagher@duke.edu.
Age Range
18-65
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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
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
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
An Open-Label, Multicenter, Pilot Study to Evaluate the Performance and Safety of NeuraGen® 3D Nerve Guide Matrix.
Principal Investigator
Suhail
Mithani
Protocol Number
PRO00105103
NCT ID
NCT05343143
Phase
IV
Enrollment Status
OPEN TO ACCRUAL