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ACTIVE NOT RECRUITING
NCT06369233
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

MegaShield®-SP

MegaShield®-SP application Lumbar discectomy or laminectomy

DEVICE

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