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:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT06386666
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years old, gender unlimited;
2. Meet the diagnosis of lumbar disc herniation (refer to the Guidelines for Diagnosis and Treatment of Lumbar disc herniation), and expect to undergo single-level disc nucleus pulposus extraction;
3. The history of lumbar disc herniation is more than 6 weeks, and systematic conservative treatment is ineffective；
4. ODI index ≥20 points;
5. In the VAS score of bilateral lower limbs, at least one side was ≥4 points;
6. The score of the three evaluation indicators according to the modified Pfirrmann grade, age and disc height is no more than 7 points (see Annex 1 for the criteria);
7. Voluntarily participate and sign informed consent;
8. Be able to communicate well with research doctors, have good compliance, and can follow the requirements of clinical research.
Exclusion Criteria:
1. Laboratory examination (blood routine examination, blood biochemistry, coagulation function and blood pregnancy, etc.), imaging examination (MRI) and vital signs examination have abnormal results with clinical significance, and the researchers believe that they are not suitable for inclusion;
2. Active local or systemic infection;
3. Patients with lumbar tumors and/or spinal malformations;
4. Imaging showed calcification of the posterior longitudinal ligament;
5. A history of serious diseases of important organs (such as cardiovascular system, liver, lung, kidney and nervous system);
6. There are autoimmune diseases or abnormal coagulation function;
7. Previous or planned surgical procedures to fuse or stabilize the lumbar spine during the trial;
8. Intraoperative exploration of the location of the annulus fibriatus could not satisfy the requirement that the needle entry point was more than 2mm away from the margin of the annulus fibriatus;
9. Pregnant or lactating women, or those who have a pregnancy plan during the trial period;
10. Those who are participating in other clinical trials at the same time;
11. Other situations that the researcher considers inappropriate to participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06386666
Study Brief:
Protocol Section:
NCT06386666