Can a dissolvable glue seal the brain and stop leaks after surgery?
NCT ID NCT07768553
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This clinical trial is testing whether a new absorbable adhesive can help seal the protective lining of the brain (the dura) after neurosurgery, preventing cerebrospinal fluid leaks. The study involves 132 adults who are having brain or spinal surgery and are at risk of such leaks. Participants are randomly assigned to receive either the new adhesive or an existing sealing film, and the success of the seal is checked about a week after surgery. The goal is to see if the new adhesive works as well as the current option, with fewer complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- An absorbable medical adhesive made of polyethylene glycol (PEG) derivatives that forms a hydrogel to seal the dura during neurosurgery.
- What this could lead to
- If effective, this adhesive could offer a new way to prevent cerebrospinal fluid leaks after brain or spinal surgery, potentially reducing complications and the need for additional procedures.
- What could go wrong
- This is a Phase 3 trial with a relatively small number of participants (132). The adhesive may not be as effective as the existing sealing film, and there are risks of infection, swelling, or other surgical complications.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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132 people
The number who actually took part.
- Started
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Nov 2017
- Finished
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Sep 2021
- 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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18 to 75 years
- 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: * Age ≥ 18 years and ≤ 75 years, any gender. * Patients undergoing neurosurgical dural (or spinal dural) repair who are at risk of CSF leakage or who have already developed CSF leakage and require adjunctive repair. * Patient and/or legal guardian has provided written informed consent. Exclusion Criteria: * Participated in another clinical trial within 1 month prior to screening. * Body temperature ≥ 37.3°C within 3 days prior to screening. * Severe diseases of vital organs (heart, liver, kidney) or hematological diseases that would make the patient intolerant to surgery. * History of severe allergies or severe immunodeficiency. * Life expectancy \< 3 months. * Pregnant or breastfeeding women, or women of childbearing age with positive pregnancy test; male or female subjects not using effective contraception or planning to conceive within 3 months after study initiation. * Poor compliance as judged by the investigator. * Unable to understand the study description. * Any other condition deemed unsuitable for participation as judged by the investigator.
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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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General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
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Huazhong University of Science and Technology Union Shenzhen Hospital (Shenzhen Nanshan People's Hospital)
Shenzhen, Guangdong, China
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Qinghai Provincial People's Hospital
Xining, Qinghai, China
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Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
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Tangdu Hospital, Air Force Medical University
Xi'an, Shaanxi, China
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
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The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
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The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
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The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
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