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

Spine Surgery Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016739
• Other study ID #: CADISS 1701
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2021
• Source: AuXin Surgery SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Spine Surgery

Intervention

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.

Locations

Country	Name	City	State
Belgium	AuXin Surgery	Louvain-la-Neuve

Sponsors (1)

Lead Sponsor	Collaborator
AuXin Surgery SA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of the CADISS® System to dissect fibrosis without cutting	Percentage of successful dissection	Surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The ease of use of the CADISS System	Likert scale - 0 to 10. A score of 0 representing the worse outcome	Surgery
Secondary	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
Secondary	Adverse events	All CADISS related Adverse events will be reported	surgery, at hospital discharge minimum 1 day after surgery, 6 weeks