NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease
| NCT ID | NCT07017634 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | CGBio Inc. |
| Condition | Degenerative Disc Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2026-06-11 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 316 participants in total. It began in 2026-06-11 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07017634 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Degenerative Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07017634 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 316 participants.
Is NCT07017634 currently recruiting?
Yes, NCT07017634 is actively recruiting participants. Contact the research team at Jumi.Han@CGBioUSA.com for enrollment information.
Where is the NCT07017634 trial being conducted?
This trial is being conducted at Little Rock, United States, Sacramento, United States, Miami, United States, Baton Rouge, United States and 6 additional locations.
Who is sponsoring the NCT07017634 clinical trial?
NCT07017634 is sponsored by CGBio Inc.. The trial plans to enroll 316 participants.