NCT06369233

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Apr 2024Sep 2026

Study Start

First participant enrolled

April 1, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

April 12, 2024

Last Update Submit

March 3, 2026

Conditions

Herniation, Disc

Keywords

disc herniationlaminectomyanti-adhesiondisc resectionMegaShieldMegaShield-SP

Outcome Measures

Primary Outcomes (1)

  • MRI scar score

    Primary effectiveness endpoint (0\~4, low Scar score through MRI means better)

    At 12 weeks after surgery

Secondary Outcomes (2)

  • Oswestry Disability Index(ODI) score

    Before surgery, At 2, 12 weeks after surgery

  • Visual Analog Scale(VAS) Back & Leg Pain Score

    Before surgery, At 2, 12 weeks after surgery

Study Arms (2)

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.

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.

Device: Guardix-SP Plus

Interventions

MegaShield®-SPDEVICE

MegaShield®-SP application Lumbar discectomy or laminectomy

MegaShield®-SP
Guardix-SP PlusDEVICE

Guardix-SP Plus application Lumbar discectomy or laminectomy

Guardix-SP Plus

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bundang Seoul National University Hospital

Seongnam-si, 13620, South Korea

Location

Eunpyeong ST. Mary's Hospital

Seoul, 03312, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Siyoung Park

    Yonsei University College of Medicine, Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 16, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(4)