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

NCT05016739 | Completed

• 1 other identifier: CADISS 1701
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Surgery

Keywords

spine; lumbar; surgery; revision; CADISS; fibrosis; chemically assisted dissection

Outcome Measures

Primary Outcomes (1)

• Ability of the CADISS® System to dissect fibrosis without cutting

  Percentage of successful dissection

  Surgery

Secondary Outcomes (8)

• Global satisfaction score when using the

  Surgery

• The facilitation of fibrosis detachment with the CADISS System

  Surgery

• The reduction of bleeding with the use of the CADISS System

  Surgery

• The capability of the CADISS system to highlights cleavage plane

  Surgery

• The speed of action of the mesna solution after local instillation

  Surgery

Study Arms (1)

CADISS System

EXPERIMENTAL

Device: CADISS

Interventions

CADISS DEVICE

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.

CADISS System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• AuXin Surgery SA: lead

Study Sites (1)

AuXin Surgery

Louvain-la-Neuve, 1348, Belgium

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alphonse Lubansu, MD

  University Hospital Erasme, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 23, 2021
• Study Start: October 22, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

BE (1)