Endoscopic uniportal unilateral laminotomy with bilateral decompression (ULBLD) for lumbar spinal stenosis
Official title: Bilateral Lumbar Decompression Via Uniportal Endoscopic Laminotomy in Patients With Lumbar Spinal Stenosis: Multicentric Case Series
Run by TecSalud Investigación Clínica · NCT07045714 · Data updated 2026-11-12
This study will try a minimally invasive endoscopic uniportal unilateral laminotomy with bilateral decompression (ULBLD) to relieve nerve-compression symptoms in adults with lumbar spinal stenosis who have not improved after at least three months of conservative care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 74 Years |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | TecSalud Investigación Clínica Academic / other |
| Locations | 1 site (San Pedro Garza García, Nuevo León) |
| Status | Recruiting |
| Started | February 25, 2026 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07045714 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 74 with radiographic lumbar stenosis grade I–III who have radicular or myelopathic symptoms, have completed at least three months of conservative management, and have chosen ULBLD without prior surgery at the treated levels.
✕Probably not a fit
Patients with lumbar instability, prior surgery at the target levels, active infection, certain rheumatologic conditions, congenital spinal malformations, concurrent disc herniation at the treated level, or T2 spinal cord hyperintensity on MRI are unlikely to be eligible or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective multicenter case series will enroll 78 adults with lumbar spinal stenosis at three Mexican institutions to receive ULBLD using an endoscopic uniportal technique. The procedure uses a single small incision to decompress nerve roots while aiming to spare muscle and soft tissue compared with open laminectomy. Primary outcomes include changes in neurological deficits and disability, and secondary outcomes include hospital stay, operative time, blood loss, and postoperative complications. Patients will be followed after surgery to document clinical outcomes and safety across sites.
Why it matters
Potential benefit: If successful, the procedure could relieve nerve-compression symptoms with less tissue damage, lower blood loss, shorter hospital stays, and faster recovery than traditional open surgery.
How similar studies have gone: Other minimally invasive and endoscopic decompression techniques have shown promising results in small series, but uniportal ULBLD is relatively new and lacks large randomized comparisons.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of informed consent to participate in the study. * Age ≥18 years and \<75 years. * Patients with lumbar spinal stenosis grade I-III according to the Lee scale. * Radicular or myelopathic symptoms. * Having undergone complete conservative management, including physical therapy and analgesia, for at least 3 months. * Patients who have opted for ULBLD using endoscopic uniportal technique for lumbar spinal stenosis. Exclusion Criteria: * Inability to read or write. * Prior lumbar surgeries at the levels to be treated. * Infectious symptoms or concomitant rheumatologic diseases. * Criteria of lumbar vertebral instability. * Congenital spinal malformations. * Disc herniation at the same lumbar level to be operated on. * Medullary hyperintensity on T2-weighted magnetic resonance imaging in the levels to be treated.
Where it's running
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Hospital Zambrano Hellion, TecSalud
San Pedro Garza García, Nuevo León, Mexico Recruiting
Study contacts
- Principal investigator: Mario Benvenutti Regato, MD — TecSalud Investigación Clínica
- Study coordinator: Mario Benvenutti Regato, MD
- Email: mbenreg@tec.mx
- Phone: (+52) 81 8888 0675
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.