Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery

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)

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.

Study Overview

• Status: Completed
• Conditions: Spine Surgery
• Intervention / Treatment: Device: CADISS

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Louvain-la-Neuve, Belgium, 1348
    • AuXin Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CADISS System

Device: CADISS; The CADISS® device was procured from AuXin Surgery. It consists in three elements: 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; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of the CADISS® System to dissect fibrosis without cutting	Percentage of successful dissection	Surgery

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AuXin Surgery SA
• Investigators: Principal Investigator: Alphonse Lubansu, MD, University Hospital Erasme, Brussels, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: surgery; fibrosis; spine; lumbar; revision; CADISS; chemically assisted dissection
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: CADISS 1701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No