Herniation, DiscNCT06369233
Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery
A study testing MegaShield®-SP and Guardix-SP Plus in people with Herniation, Disc, run by L&C Bio at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Herniation, Disc
- What is being tested?
- MegaShield®-SP and Guardix-SP Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Apr 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Bundang Seoul National University Hospital
Seongnam-si, 13620
Eunpyeong ST. Mary's Hospital
Seoul, 03312
Severance Hospital
Seoul, 03722
Gangnam Severance Hospital
Seoul, 06273
About this study
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
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.
Read the 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.
- Conditions
- Herniation, Disc
- Being tested
- MegaShield®-SP, Guardix-SP Plus
- Keywords
- disc herniation, laminectomy, anti-adhesion, disc resection, MegaShield, MegaShield-SP
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MegaShield®-SPDevice
MegaShield®-SP application Lumbar discectomy or laminectomy
Guardix-SP PlusDevice
Guardix-SP Plus application Lumbar discectomy or laminectomy
| Study group | Role | What they receive |
|---|---|---|
| MegaShield®-SP | Experimental | 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. Receives: Device: MegaShield®-SP |
| Guardix-SP Plus | Active comparator | 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. Receives: Device: Guardix-SP Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI scar score
Primary effectiveness endpoint (0~4, low Scar score through MRI means better)
Measured: At 12 weeks after surgery
Secondary outcomes (2)
Oswestry Disability Index(ODI) score
Secondary effectiveness endpoint (0~50, low ODI score means better)
Measured: 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)
Measured: Before surgery, At 2, 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Apr 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniation, DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L&C Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siyoung Park, Principal investigator, Yonsei University College of Medicine, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369233
- Sponsor's protocol ID
- LNC-MS-002
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06369233
- Acronym / sponsor ID
- LNC-MS-002
- Conditions
- Herniation, Disc
- Keywords
- disc herniation, laminectomy, anti-adhesion, disc resection, MegaShield, MegaShield-SP
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- L&C BioIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MegaShield®-SP | Experimental | Device: MegaShield®-SPThe 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. |
| Guardix-SP Plus | Active comparator | Device: Guardix-SP PlusThe 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MegaShield®-SPMegaShield®-SP application Lumbar discectomy or laminectomy | Device | MegaShield®-SP |
| Guardix-SP PlusGuardix-SP Plus application Lumbar discectomy or laminectomy | Device | Guardix-SP Plus |
Primary outcome
MRI scar score
Time frame: At 12 weeks after surgery
Primary effectiveness endpoint (0~4, low Scar score through MRI means better)
2 secondary outcomes
Oswestry Disability Index(ODI) score
Time frame: Before surgery, At 2, 12 weeks after surgery
Visual Analog Scale(VAS) Back & Leg Pain Score
Time frame: Before surgery, At 2, 12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siyoung Park principal investigator
Yonsei University College of Medicine, Severance Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MegaShield®-SP and Guardix-SP Plus in people with Herniation, Disc, run by L&C Bio at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI scar score (time frame: At 12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.