Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

NCT05396495 | Unknown

• 1 other identifier: SIJ-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis

Conditions

Sacroiliitis

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline throughout the follow-up period of six months

• Safety per adverse events

  Measured by the incidence and severity of treatment related adverse events

  Baseline throughout the follow-up period of six months

Secondary Outcomes (2)

• Assess self-rated physical disability caused by low back pain

  Baseline throughout the follow-up period of six months

• Opioid intake dosage using morphine equivalency conversion

  Baseline throughout the follow-up period of six months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Treatment arm using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint

Device: NeurolyserXR

Interventions

NeurolyserXR DEVICE

Using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint

Treatment arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• FUSMobile Inc.: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Sheba Medical Center

Giv‘atayim, Israel

RECRUITING

MeSH Terms

Conditions

Sacroiliitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Glia Pesah

CONTACT

+972 52 3213525; Galia.Pesah@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pilot, Interventional, Prospective, Open label, Single Arm.

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: October 24, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)