Status:
COMPLETED
Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier®) in Spine Surgery
Lead Sponsor:
DALIM TISSEN Co., Ltd.
Conditions:
Lumbar Spinal Stenosis
Lumbar Disc Herniation
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This multicenter, randomized, subject- and evaluator-blinded, active-controlled, non-inferiority clinical trial was conducted to evaluate the efficacy and safety of Collabarrier®, a collagen-based adh...
Eligibility Criteria
Inclusion
- Male or female participants aged 19 years or older
- Patients diagnosed with lumbar disc herniation or lumbar spinal stenosis based on radiological evidence (MRI or CT) showing nerve root compression at one of the following single levels: L3-L4, L4-L5, or L5-S1
- Patients scheduled to undergo their first partial laminectomy or discectomy for the above condition
- Patients who meet at least one of the following criteria (A, B, C):
- A. Have undergone a minimum of 4 weeks of prior conservative treatment within the 6 months prior to Visit 1 (e.g., physical therapy, use of anti-inflammatory drugs, or muscle relaxants)
- B. Experience intolerable pain and are judged by the investigator to require surgery for lumbar disc herniation or spinal stenosis
- C. Have significant progression of neurological functional loss
- Patients who voluntarily provide written informed consent and are able to comply with the study procedures and visit schedule
Exclusion
- Patients who shows alergic reaction or has previous stroke to main and other ingredients or components of the medical device for this clinical test
- Patients with a medical history of brittle bone
- Patients with a medical history of fracture in lumbar region or ligament injuries by external injury
- Patients who needs to undergo a spine surgery (osteotomy allowable) in addition to partial laminectomy or percutaneous lumbar discectomy for cure of symptom
- Patients with neurological function disorder on intestine/bladder
- Patients with any of such symptoms as excessive exudation, bleeding, acute edema and infection on the part applied
- Patients with Degenerative spinal disorder (other than disc herniation or spinal stenosis) or scoliosis (Cobb's angle is 15° or bigger)
- Patients with any of lymphatic disease, coagulation disoder and/or coagulant taken
- Patients with uncontrolled diabetes that may affect the surgery or the progress after surgery based on the tester's judgment
- Patients with desmosis or autoimmune disease or who has ever taken malignant tumor treatment within 5 years before this surgery
- Patients who has ever undergone a spine surgery on the part for this surgery
- Patients who has ever taken extradural steroid treatment within 2 weeks before surgery or oral steroid drug within 10 days before surgery
- Patients who has ever taken myelogram or lumbar puncture within 24 hours before screening
- Patients with impaired immunity or clinically significant abnormalities in clinical laboratory tests at screening Patients with immunity deteriorated or who shows clinically significant abnormality in lab test items at the moment of screening
- Patients who present clinically severe impairment in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or have a mental illness that significantly affects the trial
- Participated in other clinical trials within 30 days from the screening
- A pregnant woman or lactating woman
- Patients who cannot comply with any requirement of the document form consent for this clinical test from the signing date of signature on the consent till the final day of visit
- Patients determined by the researcher to be non-conformable to this clinical trials.
Key Trial Info
Start Date :
December 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2024
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT07153822
Start Date
December 15 2022
End Date
January 29 2024
Last Update
September 22 2025
Active Locations (6)
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1
Ajou University Hospital
Seoul, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Korea University Anam Hospital
Seoul, South Korea
4
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, South Korea