Recruiting
Phase 3

Novosis Putty

Sponsor:

CGBio Inc.

Code:

NCT07017634

Conditions

Degenerative Disc Disease

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Novosis Putty

Standard of Care

Study Details

Brief summary:

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

Conditions

Degenerative Disc Disease

Study ID

NCT07017634

Start date

Jun 11, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 2 (≤50% translation) spondylolisthesis. Symptomatic lumbar degeneration (L1 to S1) that may be associated with a co-morbid condition.
  • Has a history of failure conservative treatment (e.g. bed rest, physical therapy, medications, transcutaneous electrical nerve stimulation (TENS), manipulation, and/or spinal injections) for at least 6 months
  • Has preoperative Oswestry Disability Index score ≥ 40/100 at baseline
  • Male or Female, 21-80 years of age and skeletally mature at the time of surgery
  • Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
  • Signed informed consent

Exclusion Criteria:

  • Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
  • Degenerative or lytic spondylolisthesis greater than Grade 2 (50% translation);
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
  • Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis;
  • Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;
  • Lactating, pregnant or interested in becoming pregnant in the next 3 years;
  • Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.
  • Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.

Study Design

Enrollment

316 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Novosis Putty

active comparator: Standard of Care

Interventions

Novosis Putty

Single Level TLIF surgery with Novosis Putty

Standard of Care

Single Level TLIF surgery with standard of care bone graft

Primary outcome measure

  • Overall Success [ Time Frame: 24 months after surgery ]

Central Contacts and Locations

Central contacts

Jumi Han

1.949.445.5965Jumi.Han@CGBioUSA.com

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Dana L. Garrison

501-231-1193DLGarrison@UAMS.edu

Principal Investigator:

Mark Feger, MD, Ph.D

UC Davis

Recruiting

Sacramento, California, United States, 95816

Contacts

Melanie Ann Peters

916-734-2756melpeters@health.ucdavis.edu

Principal Investigator:

Kee D. Kim, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Yamilet Nieves Vega

305-243-5998yxn176@med.miami.edu

Principal Investigator:

Michael Wang, MD

The Spine Center of Louisiana

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Ana Heully

225-515-5700aheully@saon.net

Principal Investigator:

Kevin McCarthy

LSU Health

Recruiting

Shreveport, Louisiana, United States, 71101

Contacts

Saraith Bernard

281-236-8492saraith.bernard@lsuhs.edu

Principal Investigator:

Anthony Sin

Thomas Jefferson University - Department of Neurological Surgery

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Mary Gomez

215-503-4852mary.gomez@jefferson.edu

Principal Investigator:

Joshua Heller

American Neurospine Institute, PLLC

Recruiting

Frisco, Texas, United States, 75034

Contacts

Gladcy Mathew

469-989-3768Gladcy.Mathew@hcahealthcare.com

Principal Investigator:

Ripul Panchal

West Virginia University - Department of Orthopaedics

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Jennifer Eicher

304-293-2485jeicher@hsc.wvu.edu

Principal Investigator:

Scott Daffner

More Information

Sponsor

CGBio Inc.

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by CGBio Inc. on 2026-08-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.