SacroiliitisNCT05396495
Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain
A study testing NeurolyserXR in people with Sacroiliitis, run by FUSMobile Inc. at 1 site in Israel.
Trial summary
Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sacroiliitis
- What is being tested?
- NeurolyserXR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Oct 2022to 1 Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and females, legally able and willing to participate in the study and come for follow-up visits
- Able and willing to fill the research questionnaires and to communicate with investigator and research team
- Patient with bilateral or unilateral sacroiliac joint pain of > 6 months duration
- Patients presenting with a) a positive (>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)
- Average pain score of 4 or higher in the last month, (on 0-10 scale).
Who cannot join
- Pregnant or breastfeeding patient
- Patients younger than 18 or older than 80 years
- Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
- Patients with history of lumbar and / or sacral spine surgery
- Patients with the presence of metal hardware at the lumbosacral spine
- Patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study PI)
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- Patients unable to understand and complete the research questionnaires in Hebrew.
- Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
- Patient with extensive scarring in the skin and tissue overlying the treatment area.
- Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain
Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis
Read the detailed description
Pilot, Interventional, Prospective, Open label, Single Arm study to evaluate Non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (SIJ) using High Intensity Focused Ultrasound delivered by the Neurolyser XR.
Patient would be treated and then followed for up to 6 months. Primary safety endpoint will be measured by the incidence and severity of treatment related adverse events Primary effectiveness endpoint will be measured by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 and 12 months
- Conditions
- Sacroiliitis
- Being tested
- NeurolyserXR
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurolyserXRDevice
Using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Treatment arm using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint Receives: Device: NeurolyserXR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness per pain score using numerical rating scale of 0 to 10
Pain reduction would be measured using numerical rating scale of 0 to 10 to evaluate pain and brief pain inventory questioner
Measured: Baseline throughout the follow-up period of six months
Safety per adverse events
Measured by the incidence and severity of treatment related adverse events
Measured: Baseline throughout the follow-up period of six months
Secondary outcomes (2)
Assess self-rated physical disability caused by low back pain
Roland-Morris Disability Questionnaire providing a scale of 0 to 24 when 0 is best and 24 is worst
Measured: Baseline throughout the follow-up period of six months
Opioid intake dosage using morphine equivalency conversion
Using by recording patient opioid intake using opioid equivalency chart
Measured: Baseline throughout the follow-up period of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start24 Oct 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SacroiliitisStudies 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
- Pilot, Interventional, Prospective, Open label, Single Arm.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FUSMobile Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396495
- Sponsor's protocol ID
- SIJ-001
- Status last verified
- Sep 2023
- First submitted
- 25 May 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain
- ClinicalTrials.gov ID
- NCT05396495
- Acronym / sponsor ID
- SIJ-001
- Conditions
- Sacroiliitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- FUSMobile Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 31 May 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.
Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis
Detailed description
Pilot, Interventional, Prospective, Open label, Single Arm study to evaluate Non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (SIJ) using High Intensity Focused Ultrasound delivered by the Neurolyser XR.
Patient would be treated and then followed for up to 6 months. Primary safety endpoint will be measured by the incidence and severity of treatment related adverse events Primary effectiveness endpoint will be measured by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot, Interventional, Prospective, Open label, Single Arm.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: NeurolyserXRTreatment arm using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male and females, legally able and willing to participate in the study and come for follow-up visits
- Able and willing to fill the research questionnaires and to communicate with investigator and research team
- Patient with bilateral or unilateral sacroiliac joint pain of > 6 months duration
- Patients presenting with a) a positive (>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)
- Average pain score of 4 or higher in the last month, (on 0-10 scale).
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding patient
- Patients younger than 18 or older than 80 years
- Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
- Patients with history of lumbar and / or sacral spine surgery
- Patients with the presence of metal hardware at the lumbosacral spine
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 |
|---|---|---|
| NeurolyserXRUsing the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint | Device | Treatment arm |
Primary outcome
Effectiveness per pain score using numerical rating scale of 0 to 10
Time frame: Baseline throughout the follow-up period of six months
Pain reduction would be measured using numerical rating scale of 0 to 10 to evaluate pain and brief pain inventory questioner
Safety per adverse events
Time frame: Baseline throughout the follow-up period of six months
Measured by the incidence and severity of treatment related adverse events
2 secondary outcomes
Assess self-rated physical disability caused by low back pain
Time frame: Baseline throughout the follow-up period of six months
Opioid intake dosage using morphine equivalency conversion
Time frame: Baseline throughout the follow-up period of six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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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 NeurolyserXR in people with Sacroiliitis, run by FUSMobile Inc. at 1 site in Israel.
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 5 inclusion and 10 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 7 Sep 2023. 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 Israel. 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 Glia Pesah (+972 52 3213525, Galia.Pesah@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness per pain score using numerical rating scale of 0 to 10 (time frame: Baseline throughout the follow-up period of six 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 7 Sep 2023.