NeuraGen 3D Pilot Study (NCT05343143) | Clinical Trial Compass
TerminatedNot Applicable
NeuraGen 3D Pilot Study
Stopped: Slow Enrollment, Sponsor Decision
United States1 participantsStarted 2022-05-15
Plain-language summary
This is a 10-subject, 12-month follow-up, prospective, multi-center, open-label, single arm clinical trial designed to understand the initial performance characteristics and confirm the safety profile of the NeuraGen 3D Nerve Guide Matrix.
Who can participate
Age range18 Years – 65 Years
SexALL
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Key Inclusion Criteria:
* 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.
* Occurred less than and up to 21 days prior to the nerve repair surgery detailed in this protocol.
* In the opinion of the investigator, has a gap which can be easily closed without placing undue tension on the ends of the nerves with the device (i.e., the gap must be shorter than the maximum length of the device being used).
* Subject has adequate vascular perfusion of the target hand as assessed by the investigator
* Subject can accommodate immobilization of the injured hand post-operatively.
* Subject's contralateral hand is intact and of normal function.
Exclusion Criteria:
* Nerve to be repaired is a mixed motor nerve
* Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
* Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve.
* Subject's hand injury or general physical presentation of the target hand is of a nature which would prevent adequate measurement of functional nerve healing assessments.
* Subject has gross contamination of the wound in which the nerve to be studied in this protocol resides (i.e., presence of glass, metal, other large debris…
What they're measuring
1
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.