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Disk Herniated LumbarNCT04188236

Safety and Performance of a Hernia Blocking System

A study testing Hernia Blocking System in people with Disk Herniated Lumbar, run by NEOS Surgery at 6 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Disk Herniated Lumbar
What is being tested?
Hernia Blocking System
Type of treatment
Medical device
How many people
30 participants
Where
6 sitesSpain
Study dates
23 Oct 2019to 26 Jun 2023
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is between 18 and 75 years of age.
  • Posterolateral disc herniation at one level between L4 and S1 with radiographic confirmation (CT and/or MRI) of neural compression.
  • At least six weeks of failed conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.
  • Minimum posterior disc height of 5 mm at the index level.
  • Radiculopathy with positive straight leg raise test.
  • ODI score of at least 40/100.
  • Subjects who are able to give voluntary informed consent to participate in the clinical investigation and from whom consent has been obtained.
  • Subject is able and willing to comply with the protocol requirements.

Who cannot join

  • Spondylolisthesis and/or instability at the index level.
  • Foraminal, extra-foraminal or central disc herniation.
  • Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.
  • Subject has scoliosis of greater than 20 degrees (both angular and rotational).
  • Less than 20 mm of interpedicular distance in the spinal canal at the index level.
  • Grossly distorted anatomy due to congenital abnormalities.
Show all 34Show fewer
  • Deformation that affect the posterior corners of the vertebra at the index level (e.g., osteophytes).
  • Endplate irregularities that, in the judgment of the surgeon, could affect the device implantation.
  • Prior surgery at the index lumbar vertebral level.
  • Radiological confirmation of severe facet joint disease or degeneration.
  • Patients diagnosed or at a high risk of osteoporosis (such as postmenopausal women and patients receiving long-term treatment with corticosteroids) who present a bone densitometry DXA T-score of less than -2.0 at the index level.
  • Cauda equina syndrome.
  • Fever, leucocytosis and/or systemic or localized active infection.
  • Systemic inflammation and/or inflammation at the implantation site.
  • Any metabolic bone disease.
  • Insulin-dependent diabetes mellitus.
  • Peripheral neuropathy.
  • Active hepatitis, AIDS or HIV.
  • Rheumatoid arthritis or other autoimmune disease.
  • Active or history of any invasive malignancy; patients with curatively-treated malignancies who have been disease-free for at least 5 years are eligible.
  • Active tuberculosis or history of tuberculosis in the past 3 years.
  • Immunologically suppressed patients.
  • Current anticoagulation therapy, unless anticoagulation therapy can be suspended for surgery.
  • Patients who have received medication (e.g., methotrexate, alendronate) that interferes with bone mineral metabolism within 4 weeks of the planned date of the index surgery.
  • Suspected or known allergies or intolerance to the implant materials.
  • Any condition that precludes the use of general anesthesia.
  • Any condition that precludes the surgical procedure.
  • Any contraindication for MRI or CT scan.
  • Class III obesity: Body mass index ≥ 40.
  • Current alcohol or recreational drug dependency.
  • Pregnant or interested in becoming pregnant in the following 24 months.
  • Breastfeeding.
  • Life expectancy less than 2 years.
  • Subject is currently participating or has participated in the previous 4 weeks in any other interventional clinical study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Spain6 sites

  • Hospital Germans Trias i Pujol

    Badalona

  • Hospital QuirónSalud Barcelona

    Barcelona

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna

Other trials in Spain

About this study

Official title: A Multi-center, Prospective Study to Evaluate the Safety and Performance of a Hernia Blocking System to Prevent Recurrent Lumbar Disc Herniation

Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation.

Being tested
Hernia Blocking System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hernia Blocking SystemDevice

    Hernia Blocking System device implanted during a lumbar discectomy procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of clinically symptomatic recurrent lumbar disc herniation

    Measured: 24 months

Secondary outcomes (11)

  1. The incidence and type of all adverse events (AE) and serious adverse events (SAE).

    Measured: 6 weeks, 6 months, 12 months, and 24 months

  2. Incidence of clinically asymptomatic recurrent disc herniation

    Measured: 6 months, 12 months, and 24 months

  3. Disc height maintenance [mm] related to baseline

    Measured: 6 weeks, 6 months, 12 months, and 24 months

  4. Change in leg and low back pain assessed by NRS (numeric rating scale), related to baseline

    0-10 NRS

    Measured: 6 weeks, 6 months, 12 months, and 24 months

  5. Change in Low back related disability according to the Oswestry Disability Index (ODI), related to baseline

    Measured: 6 weeks, 6 months, 12 months, and 24 months

  6. The change in quality of life according to EQ-5D-5L, compared to baseline

    Measured: 6 weeks, 6 months, 12 months, and 24 months

  7. The change in the patient work status, compared to baseline

    Measured: 6 weeks, 6 months, 12 months, and 24 months

  8. The change in patient neurological status: straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, compared to baseline

    Measured: 6 weeks, 6 months, 12 months, and 24 months

  9. The change in the kinematics of the intervertebral disc at the index level, compared to baseline

    Measured: 6 weeks, 6 months, 12 months, and 24 months

  10. The change in the disc degeneration (Pfirrmann scale), compared to baseline

    Measured: 6 months, 12 months, and 24 months

  11. The change in the endplate lesions (MODIC scale), compared to baseline

    Measured: 6 months, 12 months, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2019
  2. Study start23 Oct 2019
  3. Primary completion26 Jun 2023
  4. Study completion26 Jun 2023

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04188236
Sponsor's protocol ID
NEO-RA1-2018-01
Status last verified
Oct 2023
First submitted
27 Nov 2019
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Catala I, Roldan H, Fernandez-Carballal C, Dominguez-Alonso C, Alvarez-Galovich L, Godino O. A new hernia blocking system prevents lumbar disc herniation recurrence and disc degeneration: 2 years results of a multicentric clinical investigation. Brain Spine. 2025 Dec 3;6:105898. doi: 10.1016/j.bas.2025.105898. eCollection 2026.

    PubMed 41492501

  • Godino O, Fernandez-Carballal C, Catala I, Moreno A, Rimbau JM, Alvarez-Galovich L, Roldan H. A new hernia blocking system to prevent recurrent lumbar disc herniation: surgical technique, intraoperative findings and six-months post-operative outcomes. Eur Spine J. 2025 Mar;34(3):1123-1133. doi: 10.1007/s00586-024-08595-x. Epub 2024 Dec 8.

    PubMed 39648196

Questions about this trial

What is this clinical trial studying?

A study testing Hernia Blocking System in people with Disk Herniated Lumbar, run by NEOS Surgery at 6 sites in Spain.

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 8 inclusion and 34 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. 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?

Incidence of clinically symptomatic recurrent lumbar disc herniation (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04188236, which also lists 2 linked publications.

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 18 Oct 2023.

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