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Lumbar Disc HerniationPhase 46MMNCT03366779

A Post Marketing Surveillance Study

A Phase 4 study testing 6mm annular closure device in people with Lumbar Disc Herniation and Annular Disc Tear, run by Intrinsic Therapeutics at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a prospective, multi-center study to monitor the early safety and performance of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used as an adjunct to limited discectomy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
6mm annular closure device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesin 2 countries
Study dates
16 Jan 2018to Dec 2024
Phase
Phase 4
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

  • Age 18 to 75 years old (male or female).
  • Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using CT and/or MRI.
  • At least six (6) weeks of failed, conservative treatment prior to surgery, or requires immediate surgery to prevent permanent disability.
  • Minimum posterior disc height of 5mm at the index level(s).
  • Lower back pain and/or sciatica with or without spinal claudication.
  • Oswestry Questionnaire score of at least 40/100 at baseline.
  • VAS leg pain of at least 40/100 at baseline.
  • Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Who cannot join

  • Spondylolisthesis Grade II or higher.
  • Subject requires uni or bilateral facetectomy to treat leg/back pain.
  • Subject has back or non-radicular leg pain of unknown etiology.
  • Prior surgery at the index lumbar level.
  • Subject requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score less than -2.0 at the index level. For patients with a herniation at L5/S1, the average T score of L1-L4 shall be used.
  • Subject has clinically compromised vertebral bodies at the index level(s) due to any traumatic, neoplastic, metabolic, or infectious pathology.
Show all 27Show fewer
  • Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.
  • Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
  • Any metabolic disease bone disease that has not been stabilized for at least three months (e.g., Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder, etc.).
  • Subject has an active infection either systemic or local.
  • Subject has cauda equina syndrome or neurogenic bowel/bladder dysfunction.
  • Subject has severe arterial insufficiency of the legs (Screening on physical examination= patients with diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50mm of Hg at the calf or ankle level, then the patient is to be excluded) or other peripheral vascular disease).
  • Subject has significant peripheral neuropathy, patient defined as a patient with Type I or Type II diabetes or similar systemic metabolic condition causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.
  • Subject has insulin-dependent diabetes mellitus.
  • Subject is morbidly obese (defined as a body mass index >40, or weighs more than 100 lbs over ideal body weight).
  • Subject has been diagnosed with active hepatitis, AIDS, or HIV.
  • Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
  • Subject has a known allergy to titanium, polyethylene or polyester materials.
  • Subject is pregnant or interested in becoming pregnant in the next two (2) years.
  • Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
  • Subject has a history of active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years.
  • Subject is immunologically suppressed, received steroids >1 month over the past year.
  • Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery.
  • Subject has a current chemical/alcohol dependency or significant psychosocial disturbance.
  • Subject has a life expectancy of less than three (3) years.
  • Subject is currently involved in another investigational study.
  • Subject is incarcerated.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • OLVZ Aalst

    Aalst, 9300

Other trials in Belgium

Germany1 site

  • Klinikum Itzehoe

    Itzehoe, 25524

Other trials in Germany

About this study

Official title: A Post Marketing Surveillance Study To Monitor The Early Safety And Performance Of The BARRICAID® Anular Closure Device In The Treatment Of Radicular Pain Caused By Primary Lumbar Disc Herniation

This study is a prospective, multi-center study to monitor the early safety and performance of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used as an adjunct to limited discectomy.

Read the detailed description

This study is planned to collect information on use of the Barricaid ACD with an anchor width of 6mm. Other iterations of the device are made with an 8mm wide anchor. The narrower anchor was designed to optimize surgeon visualization during implantation, and has undergone all appropriate rigorous testing prior to release. Safety will be evaluated to demonstrate acceptable levels of device-related and procedure-related complications. This limited market release will allow its performance to be evaluated by examining the effects on reoperation, device deficiencies, patient pain scores and disability after discectomy with ACD.

Being tested
6mm annular closure device
Keywords
Lumbar disc herniation, reherniation
Medical subject headings
Intervertebral Disc Displacement

What participants receive

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

  • 6mm annular closure deviceDevice

    6MM Barricaid annular closure device implantation following standard lumbar discectomy

Study groups in NCT03366779
Study groupRoleWhat they receive
Surgery with 6mm ACDOtherACD medical device (non-experimental). Surgical device implantation after standard lumbar discectomy.
Receives: Device: 6mm annular closure device

What is being measured

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

  1. Device stability

    To be considered a success the subjects would require to have a lack of implant migration through 3 months after surgery

    Measured: 3 months post implantation

Secondary outcomes (4)

  1. Device condition, reoperation at index level and long term performance

    Will be analyzed and compared to available clinical and commercial data on the Barricaid device

    Measured: Through 24Month post implantation

  2. Visual Analog Scale - leg pain

    Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome.

    Measured: Through 24Month post implantation

  3. Visual Analog scale - back pain

    Change in back pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome.

    Measured: Through 24Month post implantation

  4. Oswestry Disability Index

    Change in function as measured using the Oswestry Disability Index (ODI)

    Measured: Through 24Month post implantation

Timeline

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

  1. First posted8 Dec 2017
  2. Study start16 Jan 2018
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (estimated)

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 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter non-randomized device trial
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03366779
Sponsor's protocol ID
EUBARD-CP-001-6MM
Acronym
6MM
Status last verified
Mar 2024
First submitted
28 Nov 2017
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 6mm annular closure device in people with Lumbar Disc Herniation and Annular Disc Tear, run by Intrinsic Therapeutics at 2 sites in 2 countries.

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 27 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Device stability (time frame: 3 months post implantation). 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 NCT03366779.

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 15 Mar 2024.

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