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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital nerve repair | Experimental | There is no comparator for this study. All patients are in the treatment allocated group for digital nerve repair with the TISSIUMâ„¢ Nerve Coaptation Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TISSIUMâ„¢ Nerve Coaptation Device | Device | Placement of the TISSIUMâ„¢ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of complications (CIC) related to the investigational device | CIC includes the occurrence of any of the following complications:
| through 12-months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Semmes-Weinstein monofilament (SWMF) for nerve functional recovery | Product performance will be assessed as functional nerve repair based on nerve functional recovery using Semmes-Weinstein monofilament (SWMF) at 6-months post-surgery | at 6 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randipsingh Bindra | Gold Coast University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia | ||
| Gold Coast University Hospital |
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| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Gold Coast |
| Queensland |
| 4215 |
| Australia |
| D014947 | Wounds and Injuries |