Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery
- Conditions
- Spine Surgery
- Interventions
- Device: CADISS
- Registration Number
- NCT05016739
- Lead Sponsor
- AuXin Surgery SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- ≥ 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.
- < 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CADISS System CADISS -
- Primary Outcome Measures
Name Time Method Ability of the CADISS® System to dissect fibrosis without cutting Surgery Percentage of successful dissection
- Secondary Outcome Measures
Name Time Method 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 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
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 speed of action of the mesna solution after local instillation Surgery Likert scale - 0 to 10. A score of 0 representing the worse outcome
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
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
Trial Locations
- Locations (1)
AuXin Surgery
🇧🇪Louvain-la-Neuve, Belgium