An interventional study of CADISS in Spine Surgery, sponsored by AuXin Surgery SA. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by AuXin Surgery SA · Not applicable, Interventional, and Other
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.
3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.
This study's enrollment of 21 is below the median of 50 across 2,130 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →AuXin Surgery SA is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Device: CADISS
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.
Ability of the CADISS® System to dissect fibrosis without cutting
Percentage of successful dissection
Time frame: Surgery
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
Time frame: Surgery
The facilitation of fibrosis detachment with 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Surgery
The ease of use of the CADISS System
Likert scale - 0 to 10. A score of 0 representing the worse outcome
Time frame: 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
Time frame: Surgery
Adverse events
All CADISS related Adverse events will be reported
Time frame: surgery, at hospital discharge minimum 1 day after surgery, 6 weeks
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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AuXin Surgery SA