Safety and Performance of a Hernia Blocking System

October 17, 2023 updated by: NEOS Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Barcelona, Spain
        • Hospital Quironsalud Barcelona
      • La Laguna, Spain
        • Hospital Universitario de Canarias
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of clinically symptomatic recurrent lumbar disc herniation
Time Frame: 24 months
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence and type of all adverse events (AE) and serious adverse events (SAE).
Time Frame: 6 weeks, 6 months, 12 months, and 24 months
6 weeks, 6 months, 12 months, and 24 months
Incidence of clinically asymptomatic recurrent disc herniation
Time Frame: 6 months, 12 months, and 24 months
6 months, 12 months, and 24 months
Disc height maintenance [mm] related to baseline
Time Frame: 6 weeks, 6 months, 12 months, and 24 months
6 weeks, 6 months, 12 months, and 24 months
Change in leg and low back pain assessed by NRS (numeric rating scale), related to baseline
Time Frame: 6 weeks, 6 months, 12 months, and 24 months
0-10 NRS
6 weeks, 6 months, 12 months, and 24 months
Change in Low back related disability according to the Oswestry Disability Index (ODI), related to baseline
Time Frame: 6 weeks, 6 months, 12 months, and 24 months
6 weeks, 6 months, 12 months, and 24 months
The change in quality of life according to EQ-5D-5L, compared to baseline
Time Frame: 6 weeks, 6 months, 12 months, and 24 months
6 weeks, 6 months, 12 months, and 24 months
The change in the patient work status, compared to baseline
Time Frame: 6 weeks, 6 months, 12 months, and 24 months
6 weeks, 6 months, 12 months, and 24 months
The change in patient neurological status: straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, compared to baseline
Time Frame: 6 weeks, 6 months, 12 months, and 24 months
6 weeks, 6 months, 12 months, and 24 months
The change in the kinematics of the intervertebral disc at the index level, compared to baseline
Time Frame: 6 weeks, 6 months, 12 months, and 24 months
6 weeks, 6 months, 12 months, and 24 months
The change in the disc degeneration (Pfirrmann scale), compared to baseline
Time Frame: 6 months, 12 months, and 24 months
6 months, 12 months, and 24 months
The change in the endplate lesions (MODIC scale), compared to baseline
Time Frame: 6 months, 12 months, and 24 months
6 months, 12 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NEOS Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEO-RA1-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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