Spinal Lumbar StenosisLB2CT01NCT05587465
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
A study testing Lobster Device in people with Spinal Lumbar Stenosis and Claudication, Intermittent, run by Diametros Medical srl at 1 site in Italy.
Trial summary
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Lumbar Stenosis, Claudication, Intermittent
- What is being tested?
- Lobster Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2022to 1 Oct 2025
- 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
- Male or female subjects ≥ 45 years of age.
- Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart).
- Subjects who have been symptomatic and undergoing conservative care treatment for at least 6 months.
- Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal).
- Radiographic confirmation of at least moderate spinal stenosis which narrows the central, lateral, or foraminal spinal canal at one or two contiguous levels from L1-L5. Moderate spinal stenosis is defined as 25% to 50% reduction in lateral/central foramen compared to the adjacent levels, with radiographic confirmation of any one of the following:
- Evidence of thecal sac and/or cauda equina compression.
Show all 13Show fewer
- Evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements.
- Evidence of hypertrophic facets with canal encroachment.
- Note: All imaging studies used to confirm LSS are to be completed within 3 months prior to enrollment. Radiographic (imaging) confirmation of LSS included MRI and/or CT. In the case of a transitional L5/L6 segment with a sufficiently prominent L6 spinous process, these subjects may be included by a deviation request from the applicant.
- Must present with moderately impaired Physical Function (PF) defined as a score of > 2.0 of the Zurich Claudication Questionnaire (ZCQ).
- Must be able to sit for 50 minutes without pain and to walk 15 meters (50 feet) or more .
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
Who cannot join
- Axial back pain only.
- Fixed motor deficit.
- Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or investigational device.
- Unremitting pain in any spinal position.
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy.
- Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention.
Show all 69Show fewer
- Significant instability of the lumbar spine as defined by ≥ 3mm translation or ≥ 5° angulation.
- Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips.
- Spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1-4).
- Spondylolysis (pars fracture).
- Degenerative lumbar scoliosis with a Cobb angle of > 10° at treatment level.
- Osteopenia or osteoporosis. To confirm eligibility, at the Clinical Investigator's discretion, the following subjects may have a DEXA scan performed:
- Women 65 or older ii. Postmenopausal women < age 65 iii. Subjects with major risk factors for or diagnosed with osteoporosis or osteopenia iv. If DEXA is required, exclusion is defined as a DEXA bone density measurement T score ≤ -2.5
- Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2.
- Insulin-dependent diabetes mellitus.
- Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses).
- Prior surgery of the lumbar spine.
- Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction).
- Infection in the disc or spine, past or present.
- Evidence of active (systemic or local) infection at time of surgery.
- Active systemic disease such as AIDS, HIV, hepatitis, etc.
- Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease.
- Currently undergoing immunosuppressive therapy or long-term steroid use.
- Known allergy to titanium or titanium alloys.
- Tumor in the spine or a malignant tumor except for basal cell carcinoma 25. Known or suspected history of alcohol and/or drug abuse.
- Prisoner or transient.
- Life expectancy less than two years.
- Angina, active rheumatoid arthritis, or any other systemic disease that would affect the subject's welfare or outcome of the clinical investigation.
- Any significant mental illness (e.g., major depression, schizophrenia, bipolar disorder, etc.) that could impair the consent process or ability to complete subject self-report questionnaires.
- Involved in pending litigation of the spine or worker's compensation related to the back.
- Enrolled in the treatment phase of another drug or device clinical investigation (currently or within past 30 days).
- Congenital defect of the spine.
- Pregnant or lactating.
- Any further contraindications and limitations of the device as described in the instructions for use (IFU).
- Subjects who meet any of the following criteria will be excluded from participating in this study:
- Axial back pain only.
- Fixed motor deficit.
- Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or investigational device.
- Unremitting pain in any spinal position.
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy.
- Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention.
- Significant instability of the lumbar spine as defined by ≥ 3mm translation or ≥ 5° angulation.
- Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips.
- Spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1-4).
- Spondylolysis (pars fracture).
- Degenerative lumbar scoliosis with a Cobb angle of > 10° at treatment level.
- Osteopenia or osteoporosis. To confirm eligibility, at the Clinical Investigator's discretion, the following subjects may have a DEXA scan performed:
- Women 65 or older ii. Postmenopausal women < age 65 iii. Subjects with major risk factors for or diagnosed with osteoporosis or osteopenia iv. If DEXA is required, exclusion is defined as a DEXA bone density measurement T score ≤ -2.5
- Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2.
- Insulin-dependent diabetes mellitus.
- Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses).
- Prior surgery of the lumbar spine.
- Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction).
- Infection in the disc or spine, past or present.
- Evidence of active (systemic or local) infection at time of surgery.
- Active systemic disease such as AIDS, HIV, hepatitis, etc.
- Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease.
- Currently undergoing immunosuppressive therapy or long-term steroid use.
- Known allergy to titanium or titanium alloys.
- Tumor in the spine or a malignant tumor except for basal cell carcinoma 25. Known or suspected history of alcohol and/or drug abuse.
- Prisoner or transient.
- Life expectancy less than two years.
- Angina, active rheumatoid arthritis, or any other systemic disease that would affect the subject's welfare or outcome of the clinical investigation.
- Any significant mental illness (e.g., major depression, schizophrenia, bipolar disorder, etc.) that could impair the consent process or ability to complete subject self-report questionnaires.
- Involved in pending litigation of the spine or worker's compensation related to the back.
- Enrolled in the treatment phase of another drug or device clinical investigation (currently or within past 30 days).
- Congenital defect of the spine.
- Pregnant or lactating.
- Any further contraindications and limitations of the device as described in the instructions for use (IFU).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
SS. Trinità - Reparto di Radiologia
Cagliari, Sardinia, 09121
Reparto di Radiologia, +39 0706 095867
Stefano Marcia
About this study
Official title: Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis: A Single Arm, Prospective, Mutli-Center Study
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
Read the detailed description
After being informed about the study and potential risks, patients with Lumbar Spinal Stenosis matching inclusion and exclusion criteria giving written informed consent will undergo Lobster device implantation and followed-up for 2 years for radiological and clinical assessment in a single-arm, prospective, multicentric clinical trial.
- Conditions
- Spinal Lumbar Stenosis, Claudication, Intermittent
- Being tested
- Lobster Device
- Keywords
- Radiology, Interspinous Spacer, Interventional Radiology, Neurosurgery, Vertebral surgery, Pain management, Neurogenic intermittent claudicatio, Degenerative disc disease, Percutaneous operating technique
- Medical subject headings
- Intermittent Claudication, Agnosia, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lobster DeviceDevice
Also called Interspinous Spacer implantation
The intervention is performed percutaneously using the dedicated instrument set.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Lobster device implantation Receives: Device: Lobster Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the Lobster device in comparison to an SSED-based performance goal (PG)
Efficacy success will be evaluated as a two-prong composite endpoint:
- ZCQ Responder (at least two of the three ZCQ domains)
- ≥0.5 point improvement in physical function
- ≥0.5 point improvement in symptom severity
- Mean satisfaction ≤2.5 points
- No secondary surgical intervention (SSI) including re-operations, revision, removals or supplemental fixation or clinical significant confounding treatments (i.e., epidural steroid injections at the index level, spinal cord stimulators or rhizotomies) through 12 months
Measured: 12 months
Safety of the Lobster device in comparison to an SSED-based performance goal (PG)
Safety success will be evaluated using precision-based statistics to characterize the incidence of major device- or procedure-related complications, including:
- Device integrity failure (dislodgement, migration, or deformation)
- New or persistent worsened neurological deficit at the index level
- Spinous process fractures
- Deep infection, death, or other permanent device attributed disability
Measured: 12 months
Secondary outcomes (6)
Oswestry disability index (ODI)
Oswestry disability index. Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.
Min. value 0 (better outcome) Max. value 100 (worst outcome)
Measured: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Visual Analogue Scale (VAS)
VAS (Pain regarding Back and Leg)
Min. value 0 (better outcome) Max. value 10 (worst outcome)
Measured: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Short Form SF-12
SF-12 Short Form Survey (Physical Function and Mental Health). The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Min. value 0 (worst outcome) Max. value 100 (better outcome)
Measured: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Zurich Claudication Questionnaire (ZCQ)
The questionnaire consists of three domains and uses a Likert-type scale. It includes 7 items for symptom severity with scores of 1 to 5, 5 items for functional disability with scores of 1 to 4, and 6 items for treatment satisfaction with score of 1 to 4. Higher scores indicate more severe LSS.
Measured: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Number of participants with abnormal Neurological examination findings
Neurological examination to assess and identify any abnormalities that affect function and activities of daily living. Electromyography is performed at the discretion of the investigator.
Measured: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiological status
An independent radiographic core laboratory will be used to provide an unbiased assessment of all x-rays and CT scans (pre-procedure through last follow-up assessment). All images will be evaluated in accordance with the Image Review Charter which is provided to the sites.
Radiographic evaluations include:
- Angular Range of Motion
- Translational Motion
- Device Condition
- Device Migration
- Device Dislodgement
- Bone-Implant Interface Changes
- Exuberant Bone Formation
Measured: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start5 Oct 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Lumbar StenosisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm, prospective, multicenter study
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diametros Medical srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA, Sciently di Omar Sabry, Medical Consulting srl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587465
- Sponsor's protocol ID
- 446/2022/CE
- Acronym
- LB2CT01
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 24 Oct 2022
- 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 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis: A Single Arm, Prospective, Mutli-Center Study
- ClinicalTrials.gov ID
- NCT05587465
- Acronym / sponsor ID
- LB2CT01 / 446/2022/CE
- Conditions
- Spinal Lumbar Stenosis, Claudication, Intermittent
- Keywords
- Radiology, Interspinous Spacer, Interventional Radiology, Neurosurgery, Vertebral surgery, Pain management, Neurogenic intermittent claudicatio, Degenerative disc disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Diametros Medical srlIndustry (pharma, biotech, devices)
- Collaborators
- MCRA, Sciently di Omar Sabry, Medical Consulting srl
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 20 Oct 2022 (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 aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
Detailed description
After being informed about the study and potential risks, patients with Lumbar Spinal Stenosis matching inclusion and exclusion criteria giving written informed consent will undergo Lobster device implantation and followed-up for 2 years for radiological and clinical assessment in a single-arm, prospective, multicentric clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm, prospective, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Lobster DeviceLobster device implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects ≥ 45 years of age.
- Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart).
- Subjects who have been symptomatic and undergoing conservative care treatment for at least 6 months.
- Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal).
- Radiographic confirmation of at least moderate spinal stenosis which narrows the central, lateral, or foraminal spinal canal at one or two contiguous levels from L1-L5. Moderate spinal stenosis is defined as 25% to 50% reduction in lateral/central foramen compared to the adjacent levels, with radiographic confirmation of any one of the following:
Key exclusion criteria (69 listed)
- Axial back pain only.
- Fixed motor deficit.
- Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or investigational device.
- Unremitting pain in any spinal position.
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy.
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 |
|---|---|---|
| Lobster DeviceAlso: Interspinous Spacer implantationThe intervention is performed percutaneously using the dedicated instrument set. | Device | Treatment |
Primary outcome
Effectiveness of the Lobster device in comparison to an SSED-based performance goal (PG)
Time frame: 12 months
Efficacy success will be evaluated as a two-prong composite endpoint: * ZCQ Responder (at least two of the three ZCQ domains) * ≥0.5 point improvement in physical function * ≥0.5 point improvement in symptom severity * Mean satisfaction ≤2.5 points * No secondary surgical intervention (SSI) including re-operations, revision, removals or supplemental fixation or clinical significant confounding treatments (i.e., epidural steroid injections at the index level, spinal cord stimulators or rhizotomies) through 12 months
Safety of the Lobster device in comparison to an SSED-based performance goal (PG)
Time frame: 12 months
Safety success will be evaluated using precision-based statistics to characterize the incidence of major device- or procedure-related complications, including: * Device integrity failure (dislodgement, migration, or deformation) * New or persistent worsened neurological deficit at the index level * Spinous process fractures * Deep infection, death, or other permanent device attributed disability
6 secondary outcomes
Oswestry disability index (ODI)
Time frame: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Visual Analogue Scale (VAS)
Time frame: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Short Form SF-12
Time frame: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Zurich Claudication Questionnaire (ZCQ)
Time frame: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Number of participants with abnormal Neurological examination findings
Time frame: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiological status
Time frame: Pre-treatment, 6 weeks, 3 months, 6 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lobster Device in people with Spinal Lumbar Stenosis and Claudication, Intermittent, run by Diametros Medical srl at 1 site in Italy.
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 13 inclusion and 69 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 24 Oct 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Garlatti (+39 338 784 5689, g.garlatti@diametrosmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the Lobster device in comparison to an SSED-based performance goal (PG) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 24 Oct 2022.