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New gel aims to reduce painful scarring after back surgery

NCT ID NCT06369233

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests a new gel, MegaShield-SP, to see if it prevents scar tissue after spine surgery better than an existing gel. About 80 adults aged 20-70 with a herniated disc or spinal stenosis will receive one of the two gels during surgery. Researchers will measure scar formation on MRI and track pain and disability over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Bundang Seoul National University Hospital

    Seongnam-si, 13620, South Korea

  • Eunpyeong ST. Mary's Hospital

    Seoul, 03312, South Korea

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

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