MedTrace Logo

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

NCT04327154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-09-19

No results posted yet for this study

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

DEVICE

TISSIUM™ Nerve Coaptation Device

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

Sponsors & Collaborators

  • Tissium

    lead INDUSTRY

Principal Investigators

  • Randipsingh Bindra · Gold Coast University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2024-09-10
Completion
2024-09-10

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327154 on ClinicalTrials.gov