Replacement and Extension of Connective Tissue Structure in NeurosurgeryNCT03951272
The Efficacy and Safety of Lyoplant® Onlay in Repairing Cerebral Dura Mater
A study testing Lyoplant® Onlay/DURAFORM™ Dural Graft Implant in people with Replacement and Extension of Connective Tissue Structure in Neurosurgery, run by B. Braun Medical International Trading Company Ltd. at 1 site in China.
Trial summary
Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Replacement and Extension of Connective Tissue Structure in Neurosurgery
- What is being tested?
- Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2018to 30 Aug 2019
- 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
- Surgical patients who will receive dura mater replacement in neurosurgery;
- 18 to 75 years old, either sexes;
- Patients are ready and able to accept all visits during the trial.
- Patients are willing and able to sign Informed Consent Form (ICF) to join this clinical trial.
- Related to lesions:
- Target lesion is cerebral and cerebellum dura mater defect closure, intracranial hypertension remission;
- Surgical wound classification is Class I/sterile operation and risk index category (RIC) ≤ 2.
Who cannot join
- Patients with local cerebral infection;
- Patients who suffer from systemic infection (e.g. urinary tract infection (UTI), acquired pneumonia) or any infection sign at surgical site before the surgery, with body temperature > 38.5℃, positive result in blood culture, and/or positive result in chest X-ray examination;
- Patients who are allergic to the equipment components (Such as, by asking the patient's history of allergies, doctors understand whether the patient is allergic to proteins of bovine origin or implant or not);
- There is metal implant in patient's brain and the implant will interfere the assessment on devices or surgery recovery;
- Patients in gestation period or lactation period or planned to be pregnant during the trial;
- Patients with more than 1 separated dura mater defects;
Show all 19Show fewer
- Patients with previous neurosurgery history at the same anatomic site;
- Patients with cranial open trauma;
- Patients requiring the use of dura adhesive or sealant;
- Patients whose expected survival time is less than 12 months;
- Patients received chemotherapy and/or radiotherapy within 3 months before the surgery;
- Patients who had diagnosed as malignant tumor of other parts except brain tumor, uncontrolled diabetes, septicemia, systemic collagen diseases clinically;
- Patients who had been accompanied with liver and renal dysfunction, with ALT and AST>1.5 times the upper limit of the standard, total bilirubin level > 2.5 mg/dl, creatinine level > 2.0 mg/dl;
- Patients with significant clinical coagulation disorders, Activated partial thromboplastin time (APTT) was 3 times more than ULN (upper limit of normal), international normalized ratio (INR) is ≥ 1.7, or under the treatment of Warfarin or Coumadin;
- Patients with immune system damage or autoimmune diseases (white blood cell (WBC) count is < 4000/uL or >20,000/uL);
- Patients whose serological test results show that people with hepatitis B, hepatitis C, syphilis, AIDS and other infectious diseases during screening period;
- Patients in whom subdural drainage for more than 2 days must be performed in the surgery;
- Patients who are participating other clinical trials of investigational devices/drugs;
- Patients who are not suitable for this study as determined by the investigators.
Trial locations and contacts
1 site in 1 country.
Sally Jin contact
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jianmin Zhang, 86 571 87784715, z2sjwk@sina.com
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
Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study.
- Being tested
- Lyoplant® Onlay/DURAFORM™ Dural Graft Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyoplant® Onlay/DURAFORM™ Dural Graft ImplantDevice
Lyoplant® Onlay will be used as a dura substitute for the repair of the duramater.The DURAFORM™ Dural Graft Implant will be used in the procedures where the repair or substitution of the patient's dura mater is needed.
| Study group | Role | What they receive |
|---|---|---|
| Lyoplant® Onlay | Experimental | All the model including 2.5cm×2.5cm, 5.0cm×5.0cm,2.5cm×7.5cm,7.5cm×7.5cm,10.0cm×12.5cm will be used in this study Receives: Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant |
| DURAFORM™ Dural Graft Implant | Active comparator | All the model including 2.54cm×2.54cm,5.08cm×5.08cm, 2.54cm×7.62cm, 7.62cm×7.62cm,10.16cm×12.70cm will be used in this study Receives: Device: Lyoplant® Onlay/DURAFORM™ Dural Graft Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days
Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days after the surgery (Confirmed by radiological image evaluation and physical examination on surgical site). Each patient firstly undergoes an initial CT and if necessary, MRI will be used to further examine the volume of CSF leakage.
Measured: 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start24 Jul 2018
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Replacement and Extension of Connective Tissue Structure in NeurosurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical International Trading Company Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951272
- Sponsor's protocol ID
- AAG-G-H-1715
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 May 2019. 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
- NCT03951272
- Acronym / sponsor ID
- AAG-G-H-1715
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- B. Braun Medical International Trading Company Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 15 May 2019 (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.
Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyoplant® Onlay | Experimental | Device: Lyoplant® Onlay/DURAFORM™ Dural Graft ImplantAll the model including 2.5cm×2.5cm, 5.0cm×5.0cm,2.5cm×7.5cm,7.5cm×7.5cm,10.0cm×12.5cm will be used in this study |
| DURAFORM™ Dural Graft Implant | Active comparator | Device: Lyoplant® Onlay/DURAFORM™ Dural Graft ImplantAll the model including 2.54cm×2.54cm,5.08cm×5.08cm, 2.54cm×7.62cm, 7.62cm×7.62cm,10.16cm×12.70cm will be used in this study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Surgical patients who will receive dura mater replacement in neurosurgery;
- 18 to 75 years old, either sexes;
- Patients are ready and able to accept all visits during the trial.
- Patients are willing and able to sign Informed Consent Form (ICF) to join this clinical trial.
- Target lesion is cerebral and cerebellum dura mater defect closure, intracranial hypertension remission;
Key exclusion criteria (19 listed)
- Patients with local cerebral infection;
- Patients who suffer from systemic infection (e.g. urinary tract infection (UTI), acquired pneumonia) or any infection sign at surgical site before the surgery, with body temperature > 38.5℃, positive result in blood culture, and/or positive result in chest X-ray examination;
- Patients who are allergic to the equipment components (Such as, by asking the patient's history of allergies, doctors understand whether the patient is allergic to proteins of bovine origin or implant or not);
- There is metal implant in patient's brain and the implant will interfere the assessment on devices or surgery recovery;
- Patients in gestation period or lactation period or planned to be pregnant during the trial;
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® Onlay/DURAFORM™ Dural Graft ImplantLyoplant® Onlay will be used as a dura substitute for the repair of the duramater.The DURAFORM™ Dural Graft Implant will be used in the procedures where the repair or substitution of the patient's dura mater is needed. | Device | DURAFORM™ Dural Graft Implant, Lyoplant® Onlay |
Primary outcome
Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days
Time frame: 90days
Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days after the surgery (Confirmed by radiological image evaluation and physical examination on surgical site). Each patient firstly undergoes an initial CT and if necessary, MRI will be used to further examine the volume of CSF leakage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- 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.
Sally Jin contact
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/DURAFORM™ Dural Graft Implant in people with Replacement and Extension of Connective Tissue Structure in Neurosurgery, run by B. Braun Medical International Trading Company Ltd. 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 7 inclusion and 19 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 15 May 2019. 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 Zongjie Duan (+86 10 57632775, zongjie.duan@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical successful rate without leakage of cerebrospinal fluid (CSF) 90 days (time frame: 90days). 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 15 May 2019.