Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

NCT ID: NCT05396495

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2024-12-01

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

Conditions

Sacroiliitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

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

Group Type: EXPERIMENTAL

NeurolyserXR

Intervention Type: DEVICE

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

Interventions

NeurolyserXR

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: collaborator

FUSMobile Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sheba Medical Center

Giv‘atayim, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Glia Pesah

Role: CONTACT

Galia.Pesah@sheba.health.gov.il

+972 52 3213525

Other Identifiers

SIJ-001

Identifier Type: -

Identifier Source: org_study_id