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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT03853356
Eligibility Criteria:
Inclusion Criteria:
* The patient (male or female) must be 18 years or older
* The patient must be a candidate diagnosed with either degenerative disc disease including 1-2 level (L4-L5 and/or L5-S1) or dysplasic spondylolisthesis (degree 1 or 2) or lumbar stenosis
* If the patient is of child-bearing potential, the patient confirms not to be pregnant
* The patient is able to comply with the clinical investigation-related procedures such as attending all follow-up procedures
* The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent including the use of the anonymized data for scientific publication
* The patient will not participate in another clinical investigation during this clinical investigation
Exclusion Criteria:
* General contraindications for surgical treatment are present
* The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
* The patient is currently being treated with radiation, chemotherapy, immunosuppression or steroid therapy dose equivalent of more than 5mg prednisolon
* The patient is pregnant or nursing
* Women of childbearing age who are not using a highly effective method of birth control
* The patient has acute or chronic infection at the surgical site
* The patient has a known allergy to bovine bone material
* The patient has a medical history of alcohol or drug abuse within the last year prior to the screening examination
* Vulnerable population
* Patient is currently participating, or has participated in another clinical investigation within 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03853356
Study Brief:
Protocol Section:
NCT03853356