Status:
COMPLETED
TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial
Lead Sponsor:
Tissium
Conditions:
Digital Nerve Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 the...
Eligibility Criteria
Inclusion
- Patient undergoing a repair of a proper digital nerve of the hand;
- 100% transection injury to the nerve under repair;
- Gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension;
- Clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures;
- Patient willing and able to provide a signed Patient Informed Consent Form;
- Patient willing and able to follow the study instructions and likely to complete all required study procedures and visits.
Exclusion
- Patient has a known allergy to the constituent polymer of the investigational device;
- Patient has a documented diagnosis of peripheral neuropathy;
- Patient has a history of neuropathic pain;
- Patient has a history of injury to the nerve being studied;
- Patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area);
- Patient is pregnant or nursing
- Any patient with a diagnosis of type 1 Diabetes Mellitus;
Key Trial Info
Start Date :
December 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04327154
Start Date
December 16 2022
End Date
September 10 2024
Last Update
September 19 2024
Active Locations (2)
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1
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
2
Gold Coast University Hospital
Gold Coast, Queensland, Australia, 4215