New gel aims to stop painful scarring after back surgery
NCT ID NCT07153822
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a new gel called Collabarrier® to see if it can prevent scar tissue from forming after back surgery for herniated discs or spinal stenosis. Sixty-nine adults having their first back surgery were randomly given either the new gel or an existing one. Researchers checked MRI scans and pain levels over six weeks to compare how well each gel worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Collagen-based adhesion barrier (Collabarrier®)
- What this could lead to
- If it works, this gel could reduce painful scar tissue after back surgery, helping patients recover with less pain and better mobility.
- What could go wrong
- This is a small, early-stage study with only 69 patients. The results may not apply to everyone, and the gel might not work better than existing options.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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69 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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Jan 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ajou University Hospital
Seoul, South Korea
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Asan Medical Center
Seoul, South Korea
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Korea University Anam Hospital
Seoul, South Korea
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The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, South Korea
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The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
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The Catholic University of Korea St. Vincent's Hospital
Seoul, South Korea
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