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Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain

NCT05837234 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-08-29

No results posted yet for this study

Summary

The Presidio Medical Ultra Low Frequency (ULF™) Spinal Cord Stimulation (SCS) System is intended to provide pain relief to participants who have been clinically diagnosed with chronic low back pain with or without leg pain.

Conditions

Interventions

DEVICE

ULF SCS

Ultra low frequency spinal cord stimulation

Sponsors & Collaborators

  • Presidio Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Willem Volschenk, MBCHB · Genesis Research Services

  • Mattew Green, BMBS · CerCare

  • Paul Verrills, MBBS · Monash House Research Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2025-05-19
Completion
2028-03-31
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05837234 on ClinicalTrials.gov