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OpenTrials
Completed

NCT Number: NCT05016739

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

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.

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Key information

Conditions

Spine Surgery Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AuXin Surgery

Louvain-la-Neuve, 1348, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CADISS

Device

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.

Primary outcomes

  1. Ability of the CADISS® System to dissect fibrosis without cutting

    Time frame: Surgery

    Percentage of successful dissection

Secondary outcomes

  1. Global satisfaction score when using the

    Time frame: 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

  2. The facilitation of fibrosis detachment with the CADISS System

    Time frame: 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

  3. The reduction of bleeding with the use of the CADISS System

    Time frame: 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

  4. The capability of the CADISS system to highlights cleavage plane

    Time frame: 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

  5. The speed of action of the mesna solution after local instillation

    Time frame: Surgery

    Likert scale - 0 to 10. A score of 0 representing the worse outcome

  6. The ease of use of the CADISS System

    Time frame: Surgery

    Likert scale - 0 to 10. A score of 0 representing the worse outcome

  7. The easy of control of the topical application with the CADISS System

    Time frame: Surgery

    Likert scale - 0 to 10. A score of 0 representing the worse outcome

  8. Adverse events

    Time frame: surgery, at hospital discharge minimum 1 day after surgery, 6 weeks

    All CADISS related Adverse events will be reported

Sponsors and collaborators

Lead sponsor

AuXin Surgery SA

Industry

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 23, 2021
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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