Cerebrospinal Fluid LeakESLONCT04490629
The Efficacy and Safety of a Latest Dural Substitute
A study testing Lyoplant Onlay and DURAFORM in people with Cerebrospinal Fluid Leak, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarded as the control group. 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?
- Lyoplant Onlay and DURAFORM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 1 Nov 2021
- Phase
- Interventional
- 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
- Any patient between the ages of 18 and 75 years scheduled for elective cranial surgery involving a dural incision.
- Dural defects and surgical incision was classifed as level 1
Who cannot join
- local or systemic infection.
- patients with known allergy to Equipment components
- a history of traumatic head injury
- a compromised immune system or autoimmune disease
- patients who should not participate based on the surgeon's opinion
- patients participating in any other drug or device trial.
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- expected survival time <12 months
- underwent chemoradiotherapy 3 months before randomization
- uncontrolled diabetes and malignant tumor
- women who were pregnant, lactating, or wished to become pregnant during the study;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jianmin Zhang
Hangzhou, Zhejiang, 310000
Jianmin Zhang, M.D., Ph.D., +86 0571 87784755., zjm135@zju.edu.cn
Jianmin Zhang, M.D.，Ph.D.
About this study
Official title: A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater
This prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarded as the control group. a total of 80 patients were randomized into experimental and control group (1:1).Data were collected on complications resulting in CSF leaks, surgical site infections, instrument performance parameterized other neurological complications within 30 days. Surgeons also provided data on the ease of use of the dural sealing techniques, as well as preparation and application times. The above-mentioned date were used to evaluate the efficacy and safety of Lyoplant Onlay .
- Conditions
- Cerebrospinal Fluid Leak
- Being tested
- Lyoplant Onlay, DURAFORM
- Keywords
- Dura Mater, 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.
Lyoplant OnlayDevice
Lyoplant Onlay is a kind of latest artificial Dura Mater
DURAFORMDevice
DURAFORM is a kind of conventional artificial Dura Mater
| Study group | Role | What they receive |
|---|---|---|
| DURAFORM | Other | DURAFORM was used in repairing cerebral dura mater. Receives: Device: DURAFORM |
| Lyoplant Onlay | Experimental | Lyoplant Onlay was used in repairing cerebral dura mater. Receives: Device: Lyoplant Onlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical successful rate
proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.
Measured: at 30 days post surgery
Secondary outcomes (1)
neurosurgical complication
Incidence of intracranial infection at 2 days after operation，at discharge，and at 30 days after operation
Measured: 2 days post surgery/10 days post surgery/at 30 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 posted29 Jul 2020
- Study start1 Nov 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2021 (estimated)
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jianmin zhang, M.D., Principal investigator, Department of neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490629
- Sponsor's protocol ID
- 2017-126
- Acronym
- ESLO
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The committee will debate whether to share IPD depending on the circumstances. Because some patients are unwilling to make their condition known.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater
- ClinicalTrials.gov ID
- NCT04490629
- Acronym / sponsor ID
- ESLO / 2017-126
- Conditions
- Cerebrospinal Fluid Leak
- Keywords
- Dura Mater, Cerebrospinal Fluid Leak
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 29 Jul 2020 (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 prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarded as the control group. a total of 80 patients were randomized into experimental and control group (1:1).Data were collected on complications resulting in CSF leaks, surgical site infections, instrument performance parameterized other neurological complications within 30 days. Surgeons also provided data on the ease of use of the dural sealing techniques, as well as preparation and application times. The above-mentioned date were used to evaluate the efficacy and safety of Lyoplant Onlay .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DURAFORM | Other | Device: DURAFORMDURAFORM was used in repairing cerebral dura mater. |
| Lyoplant Onlay | Experimental | Device: Lyoplant OnlayLyoplant Onlay was used in repairing cerebral dura mater. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient between the ages of 18 and 75 years scheduled for elective cranial surgery involving a dural incision.
- Dural defects and surgical incision was classifed as level 1
Key exclusion criteria (10 listed)
- local or systemic infection.
- patients with known allergy to Equipment components
- a history of traumatic head injury
- a compromised immune system or autoimmune disease
- patients who should not participate based on the surgeon's opinion
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 |
|---|---|---|
| Lyoplant OnlayLyoplant Onlay is a kind of latest artificial Dura Mater | Device | Lyoplant Onlay |
| DURAFORMDURAFORM is a kind of conventional artificial Dura Mater | Device | DURAFORM |
Primary outcome
surgical successful rate
Time frame: at 30 days post surgery
proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.
1 secondary outcome
neurosurgical complication
Time frame: 2 days post surgery/10 days post surgery/at 30 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No. The committee will debate whether to share IPD depending on the circumstances. Because some patients are unwilling to make their condition known.
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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.
jianmin zhang, M.D. principal investigator
Department of neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyoplant Onlay and DURAFORM in people with Cerebrospinal Fluid Leak, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Zhang, M.D. (+86 0571 87784755, zjm135@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical successful rate (time frame: at 30 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 29 Jul 2020.