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The CADISS® System, Chemically Assisted mechanical DISSection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments. It is based on the property of the drug mesna (Sodium 2-mercaptoethane sulfonate) to cleave the disulfide bonds responsible for the adherence of pathological tissues and for the strength of fibrosis. Revision spine surgery is more difficult than primary surgery because of the development of fibrosis and scar tissues since the first operation. Fibrosis may develop in the spinal canal and will adhere strongly to the dura mater and to the nerve roots. This study is a prospective, multi-sites, open label, single cohort clinical trial evaluating the use of CADISS medical devices to facilitate dissection of epidural fibrosis in patients who undergo a revision in spine surgery after at least one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CADISS System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CADISS | Device | The CADISS® device was procured from AuXin Surgery. It consists in three elements:
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability of the CADISS® System to dissect fibrosis without cutting | Percentage of successful dissection | Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Global satisfaction score when using the | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice | Surgery |
| The facilitation of fibrosis detachment with the CADISS System |
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Inclusion Criteria:
The age and weight of patient are defined according to the instruction for use of the CADISS System currently on the EU market.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alphonse Lubansu, MD | University Hospital Erasme, Brussels, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AuXin Surgery | Louvain-la-Neuve | 1348 | Belgium |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice |
| Surgery |
| The reduction of bleeding with the use of the CADISS System | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice | Surgery |
| The capability of the CADISS system to highlights cleavage plane | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice | Surgery |
| The speed of action of the mesna solution after local instillation | Likert scale - 0 to 10. A score of 0 representing the worse outcome | Surgery |
| The ease of use of the CADISS System | Likert scale - 0 to 10. A score of 0 representing the worse outcome | Surgery |
| The easy of control of the topical application with the CADISS System | Likert scale - 0 to 10. A score of 0 representing the worse outcome | Surgery |
| Adverse events | All CADISS related Adverse events will be reported | surgery, at hospital discharge minimum 1 day after surgery, 6 weeks |