Cerebrospinal Fluid LeakPhase 3NCT07768553
A Trial of Absorbable Medical Adhesive for Prevention of CSF Leak
A Phase 3 study testing Absorbable Medical Adhesive and TissuePatchSF (Absorbable Polymeric Tissue Sealing Film) in people with Cerebrospinal Fluid Leak, run by Medprin Regenerative Medical Technologies Co., Ltd. at 9 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebrospinal Fluid Leak
- What is being tested?
- Absorbable Medical Adhesive and TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 9 sitesChina
- Study dates
- 13 Nov 2017to 6 Sep 2021
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong
Huazhong University of Science and Technology Union Shenzhen Hospital (Shenzhen Nanshan People's Hospital)
Shenzhen, Guangdong
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Tangdu Hospital, Air Force Medical University
Xi'an, Shaanxi
Qinghai Provincial People's Hospital
Xining, Qinghai
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
About this study
Official title: A Multicenter, Randomized, Single-Blind, Positive-Controlled, Non-Inferiority Clinical Trial of Absorbable Medical Adhesive as an Adjunctive Method for Dural Repair in Neurosurgery to Prevent Cerebrospinal Fluid Leak
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.
- Conditions
- Cerebrospinal Fluid Leak
- Being tested
- Absorbable Medical Adhesive, TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)
- Keywords
- Cerebrospinal Fluid Leak
- Medical subject headings
- Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable Medical AdhesiveDevice
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.
TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Absorbable Medical Adhesive | Experimental | 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. Receives: Device: Absorbable Medical Adhesive |
| Active Comparator: TissuePatchSF (Absorbable Polymeric Tissue Sealing Film) | Active comparator | 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. Receives: Device: TissuePatchSF (Absorbable Polymeric Tissue Sealing Film) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7 ± 3 days post-surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 7 ± 3 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start13 Nov 2017
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid LeakStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Air Force Military Medical University, Second Affiliated Hospital of Shantou University Medical College, General Hospital of Ningxia Medical University, Shenzhen Second People's Hospital, Huazhong University of Science and Technology Union Shenzhen Hospital (Shenzhen Nanshan People's Hospital), Second Affiliated Hospital of Nanchang University, Qinghai People's Hospital, The First Affiliated Hospital of Nanchang University, The Affiliated Hospital of Qingdao University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768553
- Sponsor's protocol ID
- MP-CSR-YYJ2021
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-Blind, Positive-Controlled, Non-Inferiority Clinical Trial of Absorbable Medical Adhesive as an Adjunctive Method for Dural Repair in Neurosurgery to Prevent Cerebrospinal Fluid Leak
- ClinicalTrials.gov ID
- NCT07768553
- Acronym / sponsor ID
- MP-CSR-YYJ2021
- Conditions
- Cerebrospinal Fluid Leak
- Keywords
- Cerebrospinal Fluid Leak
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Air Force Military Medical University, Second Affiliated Hospital of Shantou University Medical College, General Hospital of Ningxia Medical University, Shenzhen Second People's Hospital, Huazhong University of Science and Technology Union Shenzhen Hospital (Shenzhen Nanshan People's Hospital), Second Affiliated Hospital of Nanchang University, Qinghai People's Hospital, The First Affiliated Hospital of Nanchang University, The Affiliated Hospital of Qingdao University
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 17 Aug 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Absorbable Medical Adhesive | Experimental | Device: Absorbable Medical AdhesiveSubjects 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. |
| Active Comparator: TissuePatchSF (Absorbable Polymeric Tissue Sealing Film) | Active comparator | Device: TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Absorbable Medical AdhesiveA 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. | Device | Experimental: Absorbable Medical Adhesive |
| TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)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 | Device | Active Comparator: TissuePatchSF (Absorbable Polymeric Tissue Sealing Film) |
Primary outcome
Success Rate of Postoperative Prevention of CSF Leakage
Time frame: Day 7 ± 3 days post-surgery
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.
3 secondary outcomes
Intraoperative CSF Leak Prevention Success Rate
Time frame: Intraoperative (Day of surgery)
Postoperative Subcutaneous Fluid Accumulation Rate
Time frame: Day 7 ± 3 days post-surgery
Scalp Incision Healing
Time frame: Day 7 ± 3 days post-surgery
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 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Absorbable Medical Adhesive and TissuePatchSF (Absorbable Polymeric Tissue Sealing Film) in people with Cerebrospinal Fluid Leak, run by Medprin Regenerative Medical Technologies Co., Ltd. at 9 sites in China.
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 3 inclusion and 9 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Success Rate of Postoperative Prevention of CSF Leakage (time frame: Day 7 ± 3 days post-surgery). 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 17 Aug 2026.