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

Recruiting
20 - 70 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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 details

Herniation, Disc

NCT06369233

L&C Bio

29 April 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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