Spine Surgery
Conditions
Keywords
spine, lumbar, surgery, revision, CADISS, fibrosis, chemically assisted dissection
Brief summary
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.
Interventions
DEVICECADISS
The CADISS® device was procured from AuXin Surgery. It consists in three elements: 1. A single use disposable Remote Kit, containing a sterile cartridge, which prepares the Drug Product immediately before use, and the sterile tubing for fluid connexion. The Drug Product is a 30 ml sterile 5% mesna solution of pH 7.3+/-0.5 2. Reusable stainless steel non-cutting mechanical instruments similar to those used in the normal practice, except for the provision of an internal irrigation channel bringing the Drug Product at the working edge. 3. A pedal controlled electric motor driving the peristaltic cassette included in the disposable tubing in order to control the dispensing of the Drug Product during the procedure.
Sponsors
AuXin Surgery SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years old, weight \> 30 Kg * Eligible for Spine revision surgery, at least one year after primary surgery * Agree to participate and sign the informed consent 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
* \< 18 years old * Weight ≤ 30 kg * Primary surgery * Known hypersensibility to mesna * Patient is pregnant, breastfeeding or has wish of pregnancy during the study. * Unable to sign the informed consent * Participation in any study involving an investigational drug or device within the past 3 Months. * Individuals under tutorship or trusteeship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of the CADISS® System to dissect fibrosis without cutting | Surgery | Percentage of successful dissection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The facilitation of fibrosis detachment with the CADISS System | Surgery | 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 |
| The reduction of bleeding with the use of the CADISS System | Surgery | 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 |
| The capability of the CADISS system to highlights cleavage plane | Surgery | 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 |
| Global satisfaction score when using the | Surgery | 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 |
| The ease of use of the CADISS System | Surgery | Likert scale - 0 to 10. A score of 0 representing the worse outcome |
| The easy of control of the topical application with the CADISS System | Surgery | Likert scale - 0 to 10. A score of 0 representing the worse outcome |
| Adverse events | surgery, at hospital discharge minimum 1 day after surgery, 6 weeks | All CADISS related Adverse events will be reported |
| The speed of action of the mesna solution after local instillation | Surgery | Likert scale - 0 to 10. A score of 0 representing the worse outcome |
Countries
Belgium
Outcome results
None listed