NCT06369233

Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: L&C Bio · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To evaluate preventing adhesion, the study group is compared with MegaShield®-SP or Guardix-SP Plus after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 weeks to conduct examinations and assess Questionnaires.

Conditions

• Herniation, Disc

Interventions

Type	Name	Description
DEVICE	MegaShield®-SP	MegaShield®-SP application Lumbar discectomy or laminectomy
DEVICE	Guardix-SP Plus	Guardix-SP Plus application Lumbar discectomy or laminectomy

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-05-31
• Completion: 2026-09-30
• First posted: 2024-04-16
• Last updated: 2026-03-04

Locations

4 sites across 1 country: South Korea