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: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:
• Patients aged 20 to 70 years.
• Patient diagnosed with single-level lumbar disc herniation and scheduled to perform Lumbar discectomy, or patients diagnosed with single-level spinal stenosis and scheduled to perform laminectomy.
• Patients who voluntarily decide to participate in the study and voluntarily agree in writing to the informed consent form.
Locations
Other Locations
Republic of Korea
Bundang Seoul National University Hospital
RECRUITING
Seoul
Eunpyeong ST. Mary's Hospital
RECRUITING
Seoul
Gangnam Severance Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
So young Kim
1462017@lncbio.co.kr
+82 070-7791-8940
Backup
Siyoung Park
drspine90@yuhs.ac
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 80
Treatments
Experimental: MegaShield®-SP
The study group is applied with MegaShield®-SP after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 week to conduct examinations and assess Questionnaires.
Active_comparator: Guardix-SP Plus
The study group is applied with Guardix-SP after Lumbar discectomy or laminectomy. Afterwards, they visit at 2 weeks, 12 week to conduct examinations and assess Questionnaires.
Related Therapeutic Areas
Sponsors
Leads: L&C Bio