NCT04327154

TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial

A Prospective, Multicenter, Single-arm Clinical Trial Evaluating Safety and Performance of TISSIUMTM Nerve Coaptation Device for the Repair of Digital Nerve Discontinuities Where Gap Closure Can be Achieved by Flexion of the Extremity.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Tissium · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. Additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.

Conditions

• Digital Nerve Injury

Interventions

Type	Name	Description
DEVICE	TISSIUM™ Nerve Coaptation Device	Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.

Timeline

• Start date: 2022-12-16
• Primary completion: 2024-09-10
• Completion: 2024-09-10
• First posted: 2020-03-30
• Last updated: 2024-09-19

Locations

2 sites across 1 country: Australia