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Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery
Sponsor: L&C Bio
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.
Official title: Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery: A Multicenter, Randomized, Subjects-independent Evaluator Blinded, Active-control Comparative, Non-inferior, Prospective Confirmatory Clinical Study
Key Details
Gender
All
Age Range
20 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-04-01
Completion Date
2026-09-30
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
MegaShield®-SP
MegaShield®-SP application Lumbar discectomy or laminectomy
Guardix-SP Plus
Guardix-SP Plus application Lumbar discectomy or laminectomy
Locations (4)
Bundang Seoul National University Hospital
Seongnam-si, South Korea
Eunpyeong ST. Mary's Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea