Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT06369233
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT06369233
Study Brief:
Protocol Section:
NCT06369233