Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery

April 23, 2024 updated by: L&C Bio

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

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06273
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
        • Principal Investigator:
          • Jiwon Kwon, Professor
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
        • Contact:
        • Principal Investigator:
          • Siyoung Park, Professor
      • Seoul, Korea, Republic of, 03312
        • Recruiting
        • Eunpyeong ST. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • HyungYul Kim, Professor
      • Seoul, Korea, Republic of, 13620
        • Recruiting
        • Bundang Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Hojung Kim, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

L&C Bio

Collaborators

PROMeDis

Investigators

  • Principal Investigator: Siyoung Park, Yonsei University College of Medicine, Severance Hospital
  • Principal Investigator: Jiwon Kwon, Yonsei University College of Medicine Gangnam severance Hospital
  • Principal Investigator: Hojung Kim, Bundang Seoul National University Hospital
  • Principal Investigator: HyungYul Park, Eunpyeong ST. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

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)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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