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Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

Primary Purpose

Sacroiliitis

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

NeurolyserXR

About this trial

This is an interventional treatment trial for Sacroiliitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Safety per adverse events

Measured by the incidence and severity of treatment related adverse events

Secondary Outcome Measures

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

Opioid intake dosage using morphine equivalency conversion

Using by recording patient opioid intake using opioid equivalency chart

Full Information

NCT ID

NCT05396495

First Posted

May 25, 2022

Last Updated

September 6, 2023

Sponsor

FUSMobile Inc.

Collaborators

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05396495

Brief Title

Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

Official Title

Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 24, 2022 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FUSMobile Inc.

Collaborators

Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sacroiliitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pilot, Interventional, Prospective, Open label, Single Arm.

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

NeurolyserXR

Intervention Description

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

Primary Outcome Measure Information:

Title

Effectiveness per pain score using numerical rating scale of 0 to 10

Description

Pain reduction would be measured using numerical rating scale of 0 to 10 to evaluate pain and brief pain inventory questioner

Time Frame

Baseline throughout the follow-up period of six months

Title

Safety per adverse events

Description

Measured by the incidence and severity of treatment related adverse events

Time Frame

Baseline throughout the follow-up period of six months

Secondary Outcome Measure Information:

Title

Assess self-rated physical disability caused by low back pain

Description

Roland-Morris Disability Questionnaire providing a scale of 0 to 24 when 0 is best and 24 is worst

Time Frame

Baseline throughout the follow-up period of six months

Title

Opioid intake dosage using morphine equivalency conversion

Description

Using by recording patient opioid intake using opioid equivalency chart

Time Frame

Baseline throughout the follow-up period of six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Glia Pesah

Phone

+972 52 3213525

Galia.Pesah@sheba.health.gov.il

Facility Information:

Facility Name

Sheba Medical Center

City

Givatayim

Country

Israel

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

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