A Phase 3 interventional study of Absorbable Medical Adhesive and TissuePatchSF (Absorbable Polymeric Tissue Sealing Film) in Cerebrospinal Fluid Leak, sponsored by Medprin Regenerative Medical Technologies Co., Ltd.. Completed at 9 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Medprin Regenerative Medical Technologies Co., Ltd. · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, single-blind, positive-controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of an absorbable medical adhesive (developed by Guangzhou Maipu Regenerative Medical Technology Co., Ltd.) as an adjunctive method for dural repair in neurosurgery to prevent cerebrospinal fluid (CSF) leakage. A total of 132 subjects (1:1 randomization, 66 in the test group and 66 in the control group) were enrolled across 9 centers in China. The test device is an absorbable medical adhesive composed of polyethylene glycol (PEG) derivatives. The control device is the commercially available absorbable polymeric tissue sealing film (TissuePatchSF, TissueMed Ltd., UK NMPA Registration No. 20163641547). The primary efficacy endpoint is the success rate of postoperative prevention of CSF leakage (assessed at Day 7 ± 3 days post-surgery). Secondary efficacy endpoints include intraoperative CSF leak prevention success rate, postoperative subcutaneous fluid accumulation rate, and scalp incision healing. Safety endpoints include adverse events, serious adverse events, central nervous system infection, and pseudomeningocele. Subjects were followed for 3 months post-surgery. The study was completed in April 2021.
41 studies on the registry are indexed under Cerebrospinal Fluid Leak; 9 are open to participants now.
This study's enrollment of 132 is above the median of 74 across 24 interventional studies indexed under Cerebrospinal Fluid Leak.
Browse Cerebrospinal Fluid Leak studies →Medprin Regenerative Medical Technologies Co., Ltd. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects undergoing neurosurgical dural repair (including tumor resection or dural repair) who are at risk of or have already developed CSF leakage and require adjunctive sealing. The test device is applied to the dural repair site as an adjunctive sealant.
Device: Absorbable Medical Adhesive
Subjects undergoing neurosurgical dural repair (including tumor resection or dural repair) who are at risk of or have already developed CSF leakage and require adjunctive sealing. The control device is applied to the dural repair site as an adjunctive sealant per its approved labeling.
Device: TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)
A synthetic absorbable medical adhesive composed of polyethylene glycol (PEG) derivatives (electrophilic and nucleophilic components) that crosslink to form a hydrogel upon mixing. It provides a watertight seal and enhances tissue adhesion through ionic interactions between cationic groups on the nucleophilic component and anions in tissue matrices. The product is biodegradable and has low swelling ratio.Guangzhou Maipu Regenerative Medical Technology Co., Ltd.
A synthetic absorbable polymeric tissue sealing film indicated as an adjunctive sealant for dural repair in neurosurgery. The product is applied directly to the dural repair site to provide a watertight seal. TissueMed Ltd. (UK) .NMPA Registration No.: 国械注进20163641547
Success Rate of Postoperative Prevention of CSF Leakage
Success is defined as the absence of cerebrospinal fluid (CSF) leakage at the dural repair site, assessed by imaging (CT/MRI), laboratory tests, and clinical symptoms at Day 7 ± 3 days post-surgery.
Time frame: Day 7 ± 3 days post-surgery
Intraoperative CSF Leak Prevention Success Rate
Success is defined as absence of CSF leakage at the repair site after application of the test/control device, assessed by Valsalva maneuver or other effective methods.
Time frame: Intraoperative (Day of surgery)
Postoperative Subcutaneous Fluid Accumulation Rate
Presence of subcutaneous fluid accumulation assessed by imaging (CT/MRI), laboratory tests, or clinical examination (e.g., aspiration) at Day 7 ± 3 days post-surgery.
Time frame: Day 7 ± 3 days post-surgery
Scalp Incision Healing
Assessment of surgical wound healing based on clinical examination at Day 7 ± 3 days post-surgery.
Time frame: Day 7 ± 3 days post-surgery
Incidence of Adverse Events
All adverse events, including device-related AEs, serious AEs, and device-related SAEs.
Time frame: Through study completion (up to 3 months post-surgery)
Central Nervous System Infection Rate
Incidence of CNS infection as diagnosed by clinical and laboratory findings.
Time frame: Through study completion (up to 3 months post-surgery)
Pseudomeningocele Rate
Incidence of pseudomeningocele diagnosed by imaging (CT/MRI) and clinical examination.
Time frame: Through study completion (up to 3 months post-surgery)
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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