Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369233
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-12
Brief Title:
Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield-SP in Comparison with Guardix-SP Plus After Spine Surgery
Sponsor:
LC Bio
Organization:
LC Bio
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None