Search / Trial NCT06229470

Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain

Launched by SALUDA MEDICAL PTY LTD · Jan 19, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking into a new way to help manage chronic pain, specifically pain in the back and limbs, using a device called the Evoke System. The study aims to see if measurements of nerve activity can help doctors better tailor treatment for patients experiencing severe, ongoing pain that hasn’t responded to other treatments. Participants will be individuals who are planning to undergo a temporary trial with this system and have significant pain levels, specifically a score of 6 or higher on a scale used to measure pain.

To be eligible for this trial, participants must be between the ages of 18 and 74, able to read and understand English, and willing to provide informed consent. This means they should be ready to learn about the study and agree to take part. The trial is currently recruiting, so those who fit the criteria can expect to undergo a series of assessments and visits related to their pain management. The goal is to find out if this new method can improve the way chronic pain is treated, offering hope for better relief for those struggling with it.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain.
  • Leg pain score ≥ 6 cm (Visual Analog Scale \[VAS\]).
  • Back pain score ≥ 6 cm (VAS).
  • Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits.
  • Subject is not pregnant and not \<18 years of age.
  • Exclusion Criteria:
  • N/A

About Saluda Medical Pty Ltd

Saluda Medical Pty Ltd is a pioneering medical technology company focused on developing innovative neuromodulation therapies for the treatment of chronic pain and other neurological disorders. With a commitment to advancing patient care through cutting-edge research and development, Saluda Medical leverages its proprietary technology platform to create solutions that enhance the effectiveness and safety of treatments. The company's dedication to clinical excellence is reflected in its robust clinical trial programs, aimed at validating the efficacy and reliability of its therapies. Through collaboration with healthcare professionals and regulatory bodies, Saluda Medical strives to improve the quality of life for patients worldwide.

Locations

Cleveland, Ohio, United States

Tyler, Texas, United States

Victoria, Texas, United States

Camarillo, California, United States

Greenville, South Carolina, United States

Delray Beach, Florida, United States

Carmel, Indiana, United States

Loveland, Ohio, United States

La Mesa, California, United States

Reno, Nevada, United States

Clifton, New Jersey, United States

Louisville, Kentucky, United States

Grand Island, Nebraska, United States

Lake Havasu City, Arizona, United States

Walnut Creek, California, United States

Jasper, Georgia, United States

Rockford, Illinois, United States

Wilmington, North Carolina, United States

Santa Rosa, California, United States

Hammond, Louisiana, United States

Des Moines, Iowa, United States

Glen Burnie, Maryland, United States

Rochester Hills, Michigan, United States

Greenwood Village, Colorado, United States

Ann Arbor, Michigan, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0