Spine SurgeryNCT05016739
Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery
A study testing CADISS in people with Spine Surgery, run by AuXin Surgery SA at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery
- What is being tested?
- CADISS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Oct 2018to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- CADISS
- Keywords
- spine, lumbar, surgery, revision, CADISS, fibrosis, chemically assisted dissection
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADISSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CADISS System | Experimental | Not described Receives: Device: CADISS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the CADISS® System to dissect fibrosis without cutting
Percentage of successful dissection
Measured: Surgery
Secondary outcomes (8)
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
Measured: Surgery
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
Measured: Surgery
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
Measured: Surgery
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
Measured: Surgery
The speed of action of the mesna solution after local instillation
Likert scale - 0 to 10. A score of 0 representing the worse outcome
Measured: Surgery
The ease of use of the CADISS System
Likert scale - 0 to 10. A score of 0 representing the worse outcome
Measured: Surgery
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
Measured: Surgery
Adverse events
All CADISS related Adverse events will be reported
Measured: surgery, at hospital discharge minimum 1 day after surgery, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start22 Oct 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AuXin Surgery SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alphonse Lubansu, MD, Principal investigator, University Hospital Erasme, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016739
- Sponsor's protocol ID
- CADISS 1701
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05016739
- Acronym / sponsor ID
- CADISS 1701
- Conditions
- Spine Surgery
- Keywords
- spine, lumbar, surgery, revision, CADISS, fibrosis, chemically assisted dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AuXin Surgery SAIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CADISS System | Experimental | Device: CADISS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (8 listed)
- < 18 years old
- Weight ≤ 30 kg
- Primary surgery
- Known hypersensibility to mesna
- Patient is pregnant, breastfeeding or has wish of pregnancy during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CADISSThe 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. | Device | CADISS System |
Primary outcome
Ability of the CADISS® System to dissect fibrosis without cutting
Time frame: Surgery
Percentage of successful dissection
8 secondary outcomes
Global satisfaction score when using the
Time frame: Surgery
The facilitation of fibrosis detachment with the CADISS System
Time frame: Surgery
The reduction of bleeding with the use of the CADISS System
Time frame: Surgery
The capability of the CADISS system to highlights cleavage plane
Time frame: Surgery
The speed of action of the mesna solution after local instillation
Time frame: Surgery
The ease of use of the CADISS System
Time frame: Surgery
The easy of control of the topical application with the CADISS System
Time frame: Surgery
Adverse events
Time frame: surgery, at hospital discharge minimum 1 day after surgery, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alphonse Lubansu, MD principal investigator
University Hospital Erasme, Brussels, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CADISS in people with Spine Surgery, run by AuXin Surgery SA at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the CADISS® System to dissect fibrosis without cutting (time frame: Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.