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| Name | Class |
|---|---|
| North Shore University Hospital | OTHER |
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The purpose of this research study is to:
test the usability and performance of the medical device Surgify Halo â„¢ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Haloâ„¢in comparison to the usual drill bit used in spine surgery ( Rosen burr).
This medical device is available for its indications for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.
The target is to enroll 30 participants in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgify Halo | Other |
| |
| State of art Rosen burr | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A burr used in spine surgery | Device | A burr used in spine surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability and performance of the medical device Surgify Halo â„¢ in revision spine surgery | Test the level of "chattering " during the use of the device and test the cutting performance of Surgify Haloâ„¢ in comparison to the usual drill bit used in spine surgery ( Rosen burr) | From enrollment to the end of the surgery until the end of the stay in the recovery room. |
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Inclusion Criteria:
Disease of the spine requiring surgery with bone removal
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Recruiting | New York | New York | 11030 | United States |
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