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

NCT ID: NCT05016739

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-22
• Study Completion Date: 2020-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CADISS System

Group Type: EXPERIMENTAL

CADISS

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AuXin Surgery SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alphonse Lubansu, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Erasme, Brussels, Belgium

Locations

AuXin Surgery

Louvain-la-Neuve, , Belgium

Countries

Belgium

Other Identifiers

CADISS 1701

Identifier Type: -

Identifier Source: org_study_id