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

Sponsor

AuXin Surgery SA (Industry)

Overall Status

Completed

CT.gov ID

NCT05016739

Collaborator

(none)

Enrollment

Location

Arm

25.3

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spine Surgery	Device: CADISS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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)

Actual Study Start Date :

Oct 22, 2018

Actual Primary Completion Date :

Nov 30, 2020

Actual Study Completion Date :

Nov 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Ability of the CADISS® System to dissect fibrosis without cutting [Surgery]
Percentage of successful dissection

Secondary Outcome Measures

Global satisfaction score when using the [Surgery]
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
The facilitation of fibrosis detachment with the CADISS System [Surgery]
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
The reduction of bleeding with the use of the CADISS System [Surgery]
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
The capability of the CADISS system to highlights cleavage plane [Surgery]
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
The speed of action of the mesna solution after local instillation [Surgery]
Likert scale - 0 to 10. A score of 0 representing the worse outcome
The ease of use of the CADISS System [Surgery]
Likert scale - 0 to 10. A score of 0 representing the worse outcome
The easy of control of the topical application with the CADISS System [Surgery]
Likert scale - 0 to 10. A score of 0 representing the worse outcome
Adverse events [surgery, at hospital discharge minimum 1 day after surgery, 6 weeks]
All CADISS related Adverse events will be reported

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.