๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2022-08-16

REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain (NCT05504499)

REFINE Study: A Prospective, Observational, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Pacific Research Institute

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIPโ„ข MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.

Who can join: Review the eligibility criteria below.

Location: Evolve Restorative Center โ€” Santa Rosa, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

  • Evolve Restorative Center โ€” Santa Rosa, California
  • The Raso Pain Center โ€” Jupiter, Florida
  • Koga Neurosurgery โ€” Slidell, Louisiana
  • National Spine and Pain Centers โ€” Oxon Hill, Maryland
  • Comprehensive & Interventional Pain Management โ€” Henderson, Nevada
  • Nevada Advanced Pain Specialists โ€” Reno, Nevada
  • Reno Tahoe Pain Associates โ€” Reno, Nevada
  • The Pain Management Center โ€” Voorhees Township, New Jersey
  • Premier Pain Treatment Institute โ€” Loveland, Ohio
  • Center for Interventional Pain and Spine โ€” Chadds Ford, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (707) 508-5527

Email: strimm@pacificresearchinstitute.care

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—