Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery
NCT06369233 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-03-04
Summary
This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied.
Conditions
- Herniation, Disc
Interventions
- DEVICE
-
MegaShield®-SP
MegaShield®-SP application Lumbar discectomy or laminectomy
- DEVICE
-
Guardix-SP Plus
Guardix-SP Plus application Lumbar discectomy or laminectomy
Sponsors & Collaborators
-
L&C Bio
lead INDUSTRY
Principal Investigators
-
Siyoung Park · Yonsei University College of Medicine, Severance Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-01
- Primary Completion
- 2026-05-31
- Completion
- 2026-09-30
Countries
- South Korea
Study Locations
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