Clinical trial NCT05016739: Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery
Official title: Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Patients Who Undergo Revision in Spine Surgery After at Least One Year (CADISS1701)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Surgery
Keywords: spine
lumbar
surgery
revision
CADISS
fibrosis
chemically assisted dissection
Lead sponsor: AuXin Surgery SA
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ability of the CADISS® System to dissect fibrosis without cutting
timeFrame: Surgery
Secondary outcomes:
measure: Global satisfaction score when using the
timeFrame: Surgery
measure: The facilitation of fibrosis detachment with the CADISS System
timeFrame: Surgery
measure: The reduction of bleeding with the use of the CADISS System
timeFrame: Surgery
measure: The capability of the CADISS system to highlights cleavage plane
timeFrame: Surgery
measure: The speed of action of the mesna solution after local instillation
timeFrame: Surgery
measure: The ease of use of the CADISS System
timeFrame: Surgery
measure: The easy of control of the topical application with the CADISS System
timeFrame: Surgery
measure: Adverse events
timeFrame: surgery, at hospital discharge minimum 1 day after surgery, 6 weeks
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: AuXin Surgery
Study officials:
affiliation: University Hospital Erasme, Brussels, Belgium
name: Alphonse Lubansu, MD
role: PRINCIPAL_INVESTIGATOR
References: