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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Herniation, Disc
• Intervention / Treatment: Device: MegaShield®-SP; Device: Guardix-SP Plus

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seongnam-si, South Korea, 13620
    • Bundang Seoul National University Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital
  • Seoul, South Korea, 03312
    • Eunpyeong St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients diagnosed with multi-level lumbar disc herniation or lumbar disectomy ,far lateral lumbar disc herniation(FLLDH).
• Patient diagnosed with spinal cord disease
• Patient who needs spinal fusion
• Patient who has previous experience in spinal surgery
• Patient diagnosed with a serious liver or kidney disease
• Patients with lymph fluid or blood clotting disorder or taking antithrombotic or antiplatelet agents
• Patients with uncontrolled diabetes that may affect surgery or postoperative progress according to the investigator's judgment,
• Patients with immunocompromised or autoimmune diseases such as rheumatoid arthritis or systemic erythematosus lupus, and severe systemic immune disease
• Patients with infectious diseases or healing disorders that can interfere with the normal healing process after surgery
• Patients who received steroid epidural injections within 2 weeks from the date of screening or who took oral steroids within 24 hours
• Patients who participated in other clinical trials within 30 days from the date of screening
• Patients who are unable to take MRI scans
• Pregnant or lactating women
• Patients who are not eligible for clinical trials according to the investigator's judgement
• Patients with a history of hypersensitivity to the main and other components of the investigational device
• Patients who are scheduled to receive myelogram or lumbar puncture within 24 hours from the application of the investigational device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: MegaShield®-SP; MegaShield®-SP application Lumbar discectomy or laminectomy
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.	Device: Guardix-SP Plus; Guardix-SP Plus application Lumbar discectomy or laminectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI scar score	Primary effectiveness endpoint (0~4, low Scar score through MRI means better)	At 12 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index(ODI) score	Secondary effectiveness endpoint (0~50, low ODI score means better)	Before surgery, At 2, 12 weeks after surgery
Visual Analog Scale(VAS) Back & Leg Pain Score	Secondary effectiveness endpoint (0~100, low VAS score means better)	Before surgery, At 2, 12 weeks after surgery

Collaborators and Investigators

• Sponsor: L&C Bio
• Collaborators: PROMeDis
• Investigators: Principal Investigator: Siyoung Park, Yonsei University College of Medicine, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: disc herniation; laminectomy; anti-adhesion; disc resection; MegaShield; MegaShield-SP
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Intervertebral Disc Displacement
• Other Study ID Numbers: LNC-MS-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No