Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

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

Study Overview

• Status: Recruiting
• Conditions: Sacroiliitis
• Intervention / Treatment: Device: NeurolyserXR

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Glia Pesah; Phone Number: +972 52 3213525; Email: Galia.Pesah@sheba.health.gov.il

Study Locations

• Israel
  • Givatayim, Israel
    • Recruiting
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult male and females, legally able and willing to participate in the study and come for follow-up visits
2. Able and willing to fill the research questionnaires and to communicate with investigator and research team
3. Patient with bilateral or unilateral sacroiliac joint pain of > 6 months duration
4. 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)
5. Average pain score of 4 or higher in the last month, (on 0-10 scale).

Exclusion Criteria:

1. Pregnant or breastfeeding patient
2. Patients younger than 18 or older than 80 years
3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
4. Patients with history of lumbar and / or sacral spine surgery
5. Patients with the presence of metal hardware at the lumbosacral spine
6. 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)
7. Patients unable to understand and complete the research questionnaires in Hebrew.
8. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
9. Patient with extensive scarring in the skin and tissue overlying the treatment area.
10. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Treatment arm using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint	Device: NeurolyserXR; Using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline throughout the follow-up period of six months

Collaborators and Investigators

• Sponsor: FUSMobile Inc.
• Collaborators: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Sacroiliitis
• Other Study ID Numbers: SIJ-001

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