Evaluating MegaShield®-SP for preventing adhesions after spine surgery
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
Run by L&C Bio · NCT06369233 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether a new treatment called MegaShield®-SP can help prevent painful scar tissue after spine surgery compared to another treatment called Guardix-SP Plus.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 70 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | L&C Bio Industry-sponsored |
| Locations | 4 sites (Seoul and 3 other locations) |
| Trial ID | NCT06369233 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 20 to 70 years with single-level lumbar disc herniation or spinal stenosis scheduled for surgery.
✕Probably not a fit
Patients with multi-level disc herniation, spinal fusion needs, or serious comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares the efficacy and safety of MegaShield®-SP against Guardix-SP Plus in preventing post-surgical adhesions following lumbar discectomy or laminectomy. Participants aged 20 to 70 years who meet specific inclusion criteria will be randomly assigned to receive one of the two treatments. Follow-up assessments will occur at 2 weeks and 12 weeks post-surgery to evaluate outcomes through examinations and questionnaires. The study aims to provide insights into the effectiveness of these anti-adhesion treatments.
Why it matters
Potential benefit: If successful, this study could significantly reduce post-surgical complications related to adhesions, improving recovery outcomes for patients.
How similar studies have gone: Previous studies have shown promise in using similar anti-adhesion treatments, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Eunpyeong ST. Mary's Hospital
Seoul, Korea, Republic of Recruiting -
Severance Hospital
Seoul, Korea, Republic of Recruiting -
Gangnam Severance Hospital
Seoul, Korea, Republic of Recruiting -
Bundang Seoul National University Hospital
Seoul, Korea, Republic of Recruiting
Study contacts
- Principal investigator: Siyoung Park — Yonsei University College of Medicine, Severance Hospital
- Study coordinator: So young Kim
- Email: 1462017@lncbio.co.kr
- Phone: +82 070-7791-8940
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.