Lumbar Spinal StenosisNCT07153822
Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier®) in Spine Surgery
A study testing Collagen-based adhesion barrier and Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by DALIM TISSEN Co., Ltd. at 6 sites in South Korea.
Trial 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 adhesion barrier, compared to Guardix-sol in patients undergoing lumbar spine surgery for herniated disc or spinal… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Epidural Fibrosis
- What is being tested?
- Collagen-based adhesion barrier and Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 15 Dec 2022to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Ajou University Hospital
Seoul
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea St. Vincent's Hospital
Seoul
About this study
Official title: The Multi-center, Randomized, Subject/Evaluator Blind, Active-controlled, Non-inferiority Pivotal Clinical Study to Compare the Efficacy and Safety of Collabarrier® With Guardix-sol for the Prevention of Postoperative Adhesion After Operation for Disc Herniation or Spinal Stenosis
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 adhesion barrier, compared to Guardix-sol in patients undergoing lumbar spine surgery for herniated disc or spinal stenosis.
A total of 69 adult patients scheduled for first-time partial laminectomy or discectomy were enrolled and randomly assigned to receive either Collabarrier® or Guardix-sol. The investigational device (Collabarrier®) is a gel-type atelocollagen formulation designed to prevent postoperative adhesions by acting as a physical barrier between the dura mater and surrounding tissues.
The primary outcome was the mean MRI Scar Score at 6 weeks postoperatively, assessed by independent evaluators blinded to treatment allocation. Secondary outcomes included patient-reported pain scores using a 100-mm Visual Analog Scale (VAS) for low back and leg pain, and functional limitation assessed using the Oswestry Disability Index (ODI), measured at baseline, 3 weeks, and 6 weeks.
- Being tested
- Collagen-based adhesion barrier, Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen-based adhesion barrierDevice
Also called adhesion barrier
Porcine Atelocollagen (Type I)
Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrierDevice
Also called adhesion barrier
Sodium Hyaluronate(HA) + Sodium Carboxymethylcellulose(CMC)
| Study group | Role | What they receive |
|---|---|---|
| Collabarrier® | Experimental | Not described Receives: Device: Collagen-based adhesion barrier |
| Guardix-sol | Active comparator | Not described Receives: Device: Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean value of MRI scar score assessed by independent evalutor at 6 weeks after medical device use for clinical trial
Measured: 6 weeks after medical device application
Secondary outcomes (3)
Mean value of 100-mm Visual Analogue Scale (VAS) for back pain assessed by the subject before and at 3 and 6 weeks after medical device use for clinical trial
Measured: Baseline, 3 weeks, and 6 weeks after medical device application
Mean value of 100-mm Visual Analogue Scale (VAS) for leg pain assessed by the subject before and at 3 and 6 weeks after medical device use for clinical trial
Measured: Baseline, 3 weeks, and 6 weeks after medical device application
Mean value of Oswestry Disability Index (ODI) for limitations of daily life assessed by the subject before and at 3 and 6 weeks after medical device use for clinical trial
Measured: Baseline, 3 weeks, and 6 weeks after medical device application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start15 Dec 2022
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- DALIM TISSEN Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153822
- Sponsor's protocol ID
- DRT-04
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sponsor has not yet determined whether individual participant data (IPD) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-center, Randomized, Subject/Evaluator Blind, Active-controlled, Non-inferiority Pivotal Clinical Study to Compare the Efficacy and Safety of Collabarrier® With Guardix-sol for the Prevention of Postoperative Adhesion After Operation for Disc Herniation or Spinal Stenosis
- ClinicalTrials.gov ID
- NCT07153822
- Acronym / sponsor ID
- DRT-04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- DALIM TISSEN Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 adhesion barrier, compared to Guardix-sol in patients undergoing lumbar spine surgery for herniated disc or spinal stenosis.
A total of 69 adult patients scheduled for first-time partial laminectomy or discectomy were enrolled and randomly assigned to receive either Collabarrier® or Guardix-sol. The investigational device (Collabarrier®) is a gel-type atelocollagen formulation designed to prevent postoperative adhesions by acting as a physical barrier between the dura mater and surrounding tissues.
The primary outcome was the mean MRI Scar Score at 6 weeks postoperatively, assessed by independent evaluators blinded to treatment allocation. Secondary outcomes included patient-reported pain scores using a 100-mm Visual Analog Scale (VAS) for low back and leg pain, and functional limitation assessed using the Oswestry Disability Index (ODI), measured at baseline, 3 weeks, and 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collabarrier® | Experimental | Device: Collagen-based adhesion barrier |
| Guardix-sol | Active comparator | Device: Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen-based adhesion barrierAlso: adhesion barrierPorcine Atelocollagen (Type I) | Device | Collabarrier® |
| Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrierAlso: adhesion barrierSodium Hyaluronate(HA) + Sodium Carboxymethylcellulose(CMC) | Device | Guardix-sol |
Primary outcome
Mean value of MRI scar score assessed by independent evalutor at 6 weeks after medical device use for clinical trial
Time frame: 6 weeks after medical device application
3 secondary outcomes
Mean value of 100-mm Visual Analogue Scale (VAS) for back pain assessed by the subject before and at 3 and 6 weeks after medical device use for clinical trial
Time frame: Baseline, 3 weeks, and 6 weeks after medical device application
Mean value of 100-mm Visual Analogue Scale (VAS) for leg pain assessed by the subject before and at 3 and 6 weeks after medical device use for clinical trial
Time frame: Baseline, 3 weeks, and 6 weeks after medical device application
Mean value of Oswestry Disability Index (ODI) for limitations of daily life assessed by the subject before and at 3 and 6 weeks after medical device use for clinical trial
Time frame: Baseline, 3 weeks, and 6 weeks after medical device application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided. The sponsor has not yet determined whether individual participant data (IPD) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen-based adhesion barrier and Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by DALIM TISSEN Co., Ltd. at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean value of MRI scar score assessed by independent evalutor at 6 weeks after medical device use for clinical trial (time frame: 6 weeks after medical device application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.