๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-25

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease (NCT07017634)

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study

๐ŸŸข Recruiting Phase3 โš™๏ธ Medical Device Protocol Sponsor: CGBio Inc.

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

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study

Who can join: Review the eligibility criteria below.

Location: University of Arkansas for Medical Sciences โ€” Little Rock, Arkansas

Age range: 21 Years to 80 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)

  • University of Arkansas for Medical Sciences โ€” Little Rock, Arkansas
  • UC Davis โ€” Sacramento, California
  • University of Miami โ€” Miami, Florida
  • The Spine Center of Louisiana โ€” Baton Rouge, Louisiana
  • LSU Health โ€” Shreveport, Louisiana
  • Paradigm Health System / Sterling Surgical Hospital โ€” Slidell, Louisiana
  • The Ohio State University โ€” Dublin, Ohio
  • Thomas Jefferson University - Department of Neurological Surgery โ€” Philadelphia, Pennsylvania
  • American Neurospine Institute, PLLC โ€” Frisco, Texas
  • West Virginia University - Department of Orthopaedics โ€” Morgantown, West Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (949) 445-5965

Email: Jumi.Han@CGBioUSA.com

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†—