Trials / Recruiting
RecruitingNCT06661850
Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes
A Multi-Center Randomized Clinical Study of the NOCISCAN MR Spectroscopy (MRS) in Patients Treated for Discogenic Low Back Pain
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Aclarion · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan (instead of 'It') leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient."
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Fusion or TDR determined by investigator. | The surgical treatment will be decided by the treating investigator based on their clinical judgement. |
Timeline
- Start date
- 2025-06-11
- Primary completion
- 2027-09-30
- Completion
- 2027-12-31
- First posted
- 2024-10-28
- Last updated
- 2026-04-15
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06661850. Inclusion in this directory is not an endorsement.