A Phase 3 interventional study of Novosis Putty and Standard of Care in Degenerative Disc Disease, sponsored by CGBio Inc.. Recruiting at 10 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by CGBio Inc. · Phase 3, Interventional, and Treatment
Among 232 studies in Intervertebral Disc Degeneration with a site in United States — 41 open to participants now, 60 under way, 5 of them phase 3. Intervertebral Disc Degeneration · United States.
Among the 232 studies in Intervertebral Disc Degeneration with a site in United States, this one is the 14th largest by planned enrollment of the 141 interventional ones that give a count, is one of 10 that started in 2026, is one of 16 in phase 3, reaches primary completion later than 49 of the 59 other live ones, and was the 222nd registered.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
Browse Intervertebral Disc Degeneration studies →41 of the 232 studies in Intervertebral Disc Degeneration with a site in United States are open now. Recruiting first, the newest first:
Weill Medical College of Cornell University · Sites in United States
EicOsis Human Health Inc. · Sites in United States
DiscGenics, Inc. · Sites in United States
VIVEX Biologics, Inc. · Sites in United States
VB Spine, LLC · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 60 Intervertebral Disc Degeneration studies recruiting now, 29 (48%) set no upper age limit and 16 (27%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.
This study: 21 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
232 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 20 · Phase 3 18 · Phase 4 8
First in 1998; this study’s year is marked. 10 started in 2026.
This study's planned enrollment of 316 is above the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.
Median enrollment 57 across the 141 interventional studies, 118 across the 91 observational. Of the 130 that completed or were terminated, 44 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
165 of 232 have an industry lead sponsor. The 10 most frequent:
CGBio Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
CGBio Inc. has 1 study filed under Intervertebral Disc Degeneration — fewer than ten, so there is no comparison to draw.
17 of the studies in Intervertebral Disc Degeneration with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06325566Phase 3Mesoblast, Ltd.Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain | 2027-07 |
| NCT07254806Phase 3DiscGenics, Inc.A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease | 2027-11-24 |
| NCT05740176Synergy Spine SolutionsThe Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery | 2026-11 |
| NCT05037968Kuros Biosurgery AGMagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion | 2026-12 |
| NCT04388332Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)ACDF Using Structural Allograft vs. Tritanium C | 2026-12 |
Among the 232 studies in Intervertebral Disc Degeneration with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Novosis Putty
Other: Standard of Care
Single Level TLIF surgery with Novosis Putty
Single Level TLIF surgery with standard of care bone graft
Overall Success
Meet all of the following conditions: 1. Fusion success 2. Oswestry Disability Index success 3. Neurological success 4. No subsequent surgical interventions 5. No related serious event
Time frame: 24 months after surgery
Fusion Success
Fusion Success at Month 12 via CT scan and X-ray defined by the success of the 3 components: Interbody Bridging Bone from the superior to the inferior vertebral body (via CT), Angular Motion ≤ 5° (via X-ray) AND Translational Motion ≤ 3 mm at the index level (via X-ray). Secondary categorical endpoints will be summarized over time using counts and percentages.
Time frame: 12 months after surgery
Overall Success
Meet all of the following conditions: 1. Fusion success 2. Oswestry Disability Index success 3. Neurological success 4. No subsequent surgical interventions 5. No related serious event
Time frame: 6 and 12 months after surgery
Fusion Success
Fusion Success at Month 6 and Month 24 via CT scan and X-ray defined by the success of the 3 components: Interbody Bridging Bone from the superior to the inferior vertebral body (via CT), Angular Motion ≤ 5° (via X-ray) AND Translational Motion ≤ 3 mm at the index level (via X-ray). Secondary categorical endpoints will be summarized over time using counts and percentages.
Time frame: 6 and 24 months after surgery
ODI score
Evaluate Oswestry Disability Index(ODI) score/ lowest 0(best) to highest 100(worst)
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
VAS score
Evaluate Visual Analog Scale(VAS) score/ none (0 mm) to an extreme amount of pain (100mm)
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
SF-12 score
Evaluate SF-12 scores / lowest 0(worst) to highest 100(best)
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
Time to Fusion Success
Time frame: From surgery to 60 months after surgery
Time to First SSI
Time frame: From surgery to 60 months after surgery
Treatment satisfaction
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
Intraoperative variables
Surgery time, blood loss
Time frame: intraoperative
Started Jun 2026 (actual). Primary completion is estimated for Dec 2028, 30 months after the start.
How these figures are worked out, and which studies are left out of them.
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Intervertebral Disc Degeneration →
CGBio Inc.