Spinal Dural DefectPhase 3NCT07754344
Dural Medical Adhesive for Watertight Sealing in Dural Repair
A Phase 3 study testing Dural medical adhesive and Standard dural reinforcement surgery in people with Spinal Dural Defect and Cerebrospinal Fluid Leakage, run by Medprin Regenerative Medical Technologies Co., Ltd. at 6 sites in China.
Trial summary
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Dural Defect, Cerebrospinal Fluid Leakage, Spinal Neurosurgery
- What is being tested?
- Dural medical adhesive and Standard dural reinforcement surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 6 sitesChina
- Study dates
- 29 May 2024to 28 Jul 2025
- 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
- Aged 18-75 years old, any gender.
- Undergoing spinal surgery with dural incision, traumatic tear or defect requiring primary repair.
- Intraoperative confirmed CSF leakage after primary dural repair via naked eye, microscopy, Valsalva maneuver or hemostatic sponge test.
- Patient or legal guardian voluntarily signs written informed consent form.
Who cannot join
- Participated in another interventional clinical trial within 1 month before surgery.
- Severe cardiac, hepatic, renal or hematological disease unable to tolerate spinal surgery.
- Known hypersensitivity to any component of dural medical adhesive (polyethylenimine, 4-arm PEG succinimidyl glutarate, brilliant blue, ε-poly-L-lysine hydrochloride).
- History of severe anaphylaxis or immunodeficiency disorders.
- Expected survival less than 3 months post-operation.
- Pregnant, lactating female or women planning pregnancy within 3 months after surgery.
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- Poor treatment compliance judged by investigator, unable to complete full follow-up visits.
- Unable to understand trial information and cooperate with assessment.
- Intraoperative dural defect that cannot receive primary sutured repair.
- Class III contaminated surgical wound or active infection at operation site.
- Any other condition judged inappropriate for trial participation by investigator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Peking University Third Hospital
Beijing
Xuanwu Hospital, Capital Medical University
Beijing
Nanfang Hospital, Southern Medical University
Guangzhou
The First Affiliated Hospital of Nanchang University
Nanchang
Shenzhen Second People's Hospital
Shenzhen
Xi'an Honghui Hospital
Xi'an
About this study
Official title: A Multicenter, Single-blind, Randomized Controlled Clinical Trial on the Safety and Effectiveness of Dural Medical Adhesive for Watertight Sealing in Dural Repair
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage. A total of 141 patients with intraoperative CSF leakage after primary dural repair from 7 medical centers will be enrolled at a 2:1 randomization ratio (94 in adhesive group, 47 in standard treatment control group). Intraoperative watertight sealing success rate is the primary outcome. Postoperative CSF leakage rate at day 10±5 and day 90±7, drainage volume/duration, and adverse events/serious adverse events within 90 days are secondary outcomes to evaluate the safety and effectiveness of the investigational device.
Read the detailed description
The investigational product is dural medical adhesive indicated for watertight sealing of dural defects in spinal surgery to prevent CSF leakage. This superiority trial adopts a prospective, multicenter, single-blind, randomized controlled design with 7 participating neurosurgical centers across China. Eligible patients are adults with visible CSF leakage after one-layer primary dural repair confirmed by intraoperative visualization, Valsalva maneuver or hemostatic sponge test. Subjects are randomly assigned 2:1 via sealed envelopes to two groups.
Intervention group: standard primary dural repair + dural medical adhesive evenly coated on the repair site for instant watertight sealing; a second application is allowed if persistent leakage occurs after first use.
Control group: standard treatment including autologous fat/fascia/muscle graft or reinforced suture after primary repair without medical adhesive.
All participants receive follow-up at postoperative day 10±5 (Visit 1) and day 90±7 (Visit 2). Primary efficacy endpoint is intraoperative successful watertight sealing without CSF leakage. Secondary endpoints include postoperative CSF leakage incidence at two time points, postoperative drainage volume and indwelling duration, and overall safety profiles including all adverse events and serious adverse events within 90 days post-operation. Statistical analyses will be performed on Full Analysis Set (FAS) and Per Protocol Set (PPS) for efficacy, and Safety Set (SS) for safety evaluation.
- Being tested
- Dural medical adhesive, Standard dural reinforcement surgery
- Keywords
- dural repair, CSF leak, dural sealant, spinal surgery
- Medical subject headings
- Cerebrospinal Fluid Leak, Cerebrospinal Fluid Otorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural medical adhesiveDevice
After primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, evenly coat the adhesive over the sutured area. After curing, use Valsalva maneuver or hemostatic sponge test to check sealing effect. One repeated application is permitted if leakage persists. Postoperative drainage and unified follow-up schedule are performed.
Standard dural reinforcement surgeryProcedure or surgery
After primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, adopt conventional clinical reinforcement methods including autologous fat/fascia/muscle graft or supplementary suturing, without using any dural sealing adhesive products. Intraoperative sealing verification and postoperative follow-up schedule are identical to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Dural Medical Adhesive Treatment Group | Experimental | After routine primary suture repair of spinal dural defects and intraoperative confirmation of cerebrospinal fluid leakage, evenly apply the investigational dural medical adhesive to the sutured repair area. After the adhesive is fully cured, perform Valsalva maneuver / hemostatic sponge test to recheck watertight sealing status. One additional application of the adhesive is permitted if leakage persists after the first application. Postoperative routine drainage and standardized follow-up are implemented. Receives: Device: Dural medical adhesive |
| Standard Conventional Treatment Control Group | Active comparator | After routine primary suture repair of spinal dural defects with confirmed intraoperative cerebrospinal fluid leakage, adopt clinically conventional reinforcement measures: autologous fat/fascia/muscle transplantation or supplementary interrupted suturing for leak blocking, without using any dural sealing adhesive products. Recheck sealing effect intraoperatively by Valsalva maneuver / hemostatic sponge test, followed by postoperative routine drainage and identical follow-up schedule as the experimental group. Receives: Procedure: Standard dural reinforcement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Watertight Sealing Success Rate
Proportion of subjects with no intraoperative CSF leakage confirmed by direct vision, Valsalva maneuver or hemostatic sponge test after assigned intervention.
Measured: Intraoperatively (Visit 0)
Secondary outcomes (4)
Postoperative CSF Leakage Rate at Day 10±5
Incidence of clinically confirmed CSF leakage via drainage fluid volume, MRI imaging or intracranial hypotension symptoms within 10±5 days post-surgery.
Measured: Postoperative day 10±5 (Visit 1)
Postoperative CSF Leakage Rate at Day 90±7
Incidence of delayed CSF leakage, pseudomeningocele or wound CSF leakage confirmed by MRI or clinical manifestations within 90±7 days post-operation.
Measured: Postoperative day 90±7 (Visit 2)
Postoperative Drainage Volume and Drain Indwelling Duration
Daily drainage fluid volume from surgical drain and total catheter retention time for patients with postoperative drainage tube placement.
Measured: Postoperative day 10±5 (Visit 1)
Incidence of All Adverse Events and Serious Adverse Events
Overall occurrence rate of treatment-emergent adverse events and serious adverse events related or unrelated to the dural medical adhesive throughout the 90-day follow-up period.
Measured: From surgery to postoperative day 90±7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start29 May 2024
- Primary completion19 Jun 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Dural DefectStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754344
- Sponsor's protocol ID
- MP-CTP-YYJ2024
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Randomized Controlled Clinical Trial on the Safety and Effectiveness of Dural Medical Adhesive for Watertight Sealing in Dural Repair
- ClinicalTrials.gov ID
- NCT07754344
- Acronym / sponsor ID
- MP-CTP-YYJ2024
- Keywords
- dural repair, CSF leak, dural sealant, spinal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 29 May 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 10 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 prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage. A total of 141 patients with intraoperative CSF leakage after primary dural repair from 7 medical centers will be enrolled at a 2:1 randomization ratio (94 in adhesive group, 47 in standard treatment control group). Intraoperative watertight sealing success rate is the primary outcome. Postoperative CSF leakage rate at day 10±5 and day 90±7, drainage volume/duration, and adverse events/serious adverse events within 90 days are secondary outcomes to evaluate the safety and effectiveness of the investigational device.
Detailed description
The investigational product is dural medical adhesive indicated for watertight sealing of dural defects in spinal surgery to prevent CSF leakage. This superiority trial adopts a prospective, multicenter, single-blind, randomized controlled design with 7 participating neurosurgical centers across China. Eligible patients are adults with visible CSF leakage after one-layer primary dural repair confirmed by intraoperative visualization, Valsalva maneuver or hemostatic sponge test. Subjects are randomly assigned 2:1 via sealed envelopes to two groups.
Intervention group: standard primary dural repair + dural medical adhesive evenly coated on the repair site for instant watertight sealing; a second application is allowed if persistent leakage occurs after first use.
Control group: standard treatment including autologous fat/fascia/muscle graft or reinforced suture after primary repair without medical adhesive.
All participants receive follow-up at postoperative day 10±5 (Visit 1) and day 90±7 (Visit 2). Primary efficacy endpoint is intraoperative successful watertight sealing without CSF leakage. Secondary endpoints include postoperative CSF leakage incidence at two time points, postoperative drainage volume and indwelling duration, and overall safety profiles including all adverse events and serious adverse events within 90 days post-operation. Statistical analyses will be performed on Full Analysis Set (FAS) and Per Protocol Set (PPS) for efficacy, and Safety Set (SS) for safety evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dural Medical Adhesive Treatment Group | Experimental | Device: Dural medical adhesiveAfter routine primary suture repair of spinal dural defects and intraoperative confirmation of cerebrospinal fluid leakage, evenly apply the investigational dural medical adhesive to the sutured repair area. After the adhesive is fully cured, perform Valsalva maneuver / hemostatic sponge test to recheck watertight sealing status. One additional application of the adhesive is permitted if leakage persists after the first application. Postoperative routine drainage and standardized follow-up are implemented. |
| Standard Conventional Treatment Control Group | Active comparator | Procedure: Standard dural reinforcement surgeryAfter routine primary suture repair of spinal dural defects with confirmed intraoperative cerebrospinal fluid leakage, adopt clinically conventional reinforcement measures: autologous fat/fascia/muscle transplantation or supplementary interrupted suturing for leak blocking, without using any dural sealing adhesive products. Recheck sealing effect intraoperatively by Valsalva maneuver / hemostatic sponge test, followed by postoperative routine drainage and identical follow-up schedule as the experimental group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-75 years old, any gender.
- Undergoing spinal surgery with dural incision, traumatic tear or defect requiring primary repair.
- Intraoperative confirmed CSF leakage after primary dural repair via naked eye, microscopy, Valsalva maneuver or hemostatic sponge test.
- Patient or legal guardian voluntarily signs written informed consent form.
Key exclusion criteria (11 listed)
- Participated in another interventional clinical trial within 1 month before surgery.
- Severe cardiac, hepatic, renal or hematological disease unable to tolerate spinal surgery.
- Known hypersensitivity to any component of dural medical adhesive (polyethylenimine, 4-arm PEG succinimidyl glutarate, brilliant blue, ε-poly-L-lysine hydrochloride).
- History of severe anaphylaxis or immunodeficiency disorders.
- Expected survival less than 3 months post-operation.
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 |
|---|---|---|
| Dural medical adhesiveAfter primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, evenly coat the adhesive over the sutured area. After curing, use Valsalva maneuver or hemostatic sponge test to check sealing effect. One repeated application is permitted if leakage persists. Postoperative drainage and unified follow-up schedule are performed. | Device | Dural Medical Adhesive Treatment Group |
| Standard dural reinforcement surgeryAfter primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, adopt conventional clinical reinforcement methods including autologous fat/fascia/muscle graft or supplementary suturing, without using any dural sealing adhesive products. Intraoperative sealing verification and postoperative follow-up schedule are identical to the experimental group. | Procedure or surgery | Standard Conventional Treatment Control Group |
Primary outcome
Intraoperative Watertight Sealing Success Rate
Time frame: Intraoperatively (Visit 0)
Proportion of subjects with no intraoperative CSF leakage confirmed by direct vision, Valsalva maneuver or hemostatic sponge test after assigned intervention.
4 secondary outcomes
Postoperative CSF Leakage Rate at Day 10±5
Time frame: Postoperative day 10±5 (Visit 1)
Postoperative CSF Leakage Rate at Day 90±7
Time frame: Postoperative day 90±7 (Visit 2)
Postoperative Drainage Volume and Drain Indwelling Duration
Time frame: Postoperative day 10±5 (Visit 1)
Incidence of All Adverse Events and Serious Adverse Events
Time frame: From surgery to postoperative day 90±7
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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.
6 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 Dural medical adhesive and Standard dural reinforcement surgery in people with Spinal Dural Defect and Cerebrospinal Fluid Leakage, run by Medprin Regenerative Medical Technologies Co., Ltd. at 6 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 4 inclusion and 11 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 10 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 6 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?
Intraoperative Watertight Sealing Success Rate (time frame: Intraoperatively (Visit 0)). 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 10 Aug 2026.