Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery
NCT ID: NCT06369233
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
80 participants
INTERVENTIONAL
2024-04-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)
NCT04688281
Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier®) in Spine Surgery
NCT07153822
A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
NCT01491464
Efficacy and Safety of NOVOSIS Putty for Interbody Lumbar Fusion Cases
NCT07017634
A Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
NCT01491425
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
MegaShield®-SP
MegaShield®-SP application Lumbar discectomy or laminectomy
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.
Guardix-SP Plus
Guardix-SP Plus application Lumbar discectomy or laminectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MegaShield®-SP
MegaShield®-SP application Lumbar discectomy or laminectomy
Guardix-SP Plus
Guardix-SP Plus application Lumbar discectomy or laminectomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
L&C Bio
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Siyoung Park
Role: PRINCIPAL_INVESTIGATOR
Yonsei University College of Medicine, Severance Hospital
Jiwon Kwon
Role: PRINCIPAL_INVESTIGATOR
Yonsei University College of Medicine Gangnam severance Hospital
Hojung Kim
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
HyungYul Park
Role: PRINCIPAL_INVESTIGATOR
Eunpyeong St. Mary's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eunpyeong ST. Mary's Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Bundang Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LNC-MS-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.