New gel stops bleeding during spine surgery
NCT ID NCT07354178
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tested a new gel-like product that helps stop bleeding during spinal surgery. It was compared to an existing product in 130 patients with spinal stenosis, tumors, or injuries. The goal was to see if the new product works just as well and is safe to use.
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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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130 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Aug 2025
- 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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20 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. An individual who has voluntarily signed the written consent form for participating in the research as a trial subject 2. Patients aged 20 or older 3. Patients who are able to participate throughout the entire clinical trial period 4. Patient scheduled to have spinal surgery due to spinal stenosis, spinal tumor, injury, etc. 5. Patients for whom hemostasis is difficult to achieve using standard procedures 6. Patients with grade 3 or higher bleeding \* Grade 4 or 5 bleeding is reduced to grade 3 by normal procedures (compression, sutures, electrosurgical scalpel, etc.). Exclusion Criteria: 1. Pregnant women or those planning to become pregnant within 1 month after application of the collagen-based hemostat 2. Individuals with hypersensitivity to bovine-, porcine-, or animal-derived materials 3. Individuals deemed inappropriate for participation by the investigators 4. Patients who are using treatments that may affect the test results 5. Patients with active infections at the surgical site 6. Patients with contraindications to the use of local hemostatic materials
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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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Gangnam Severance Hospital
Seoul, Gangnam-gu, 06273, South Korea
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Severance Hospital, Yonsei University Health Syetem
Seoul, Seodaemun-gu, 03722, South Korea
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Yongin Severance Hospital
Yongin-si, Giheung-gu, 16995, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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