UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007147 |
|---|---|
| Receipt number | R000008394 |
| Scientific Title | Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy |
| Date of disclosure of the study information | 2012/01/26 |
| Last modified on | 2013/05/17 17:40:54 |
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Basic information
Public title
Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy
Acronym
Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy
Scientific Title
Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy
Scientific Title:Acronym
Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy
Region
| Japan |
Condition
Condition
Patients scheduled for craniotomy that entails dural incision.
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To further evaluate the safety and efficacy f the DuraSeal Dural Sealnt System used as an adjunct to sutured dural repair during cranial surgery to provide watertight closure, as well as the malfunctions of the Product, to conduct an evaluation of safety and clinical efficacy, and to verify factors likely to affect the foregoing for the purpose of achieving more appropriate use of the Product.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of Efficacy
1)Presence of CSF leakage during surgery
Evaluation of Safety
1)All post-operative adverse events
Focusing on the following
A)Presence of post-operative CSF leak.
B)Presence of suture site wound infection redness, swelling, hotness as diagnosed by Principal Investigator.
C)Presence of post-operative meningitis symptoms of brain hypertension such as fever, headaches,
vomiting, nuchal stiffness, Kernig's sign, evaluation by CSF test as diagnosed by Principal Investigator.
2)Malfunctions of the Product defined as any mechanical failure of a device during use that results in an inability to deliver the liquid precursors Product malfunctions do not include assembly errors.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled for craniotomy that entails dural incision.
2) Written informed consent is obtained from the subject or the subject's legal representative.
Key exclusion criteria
1) Patient has active infection at surgical site.
2) Patient has impaired renal or hepatic function as diagnosed by Principal Investigator.
3) Patient has immune disorder.
4) Patient has traumatic injuries to the head.
5) Patient has dural gap exceeding 2mm.
6) Patient undergoing a contaminated cranial procedure that entails a dural incision involving perforation (other than superficial) of the sinus or mastoid air cells.
7) Patient undergoing procedures involving petrous bone drilling.
8) Patient surgery requires the use of non-autologous duraplasty materials.
9) Patient surgery requires DuraSeal application to confined bony structures where nerves are present.
10) Patient younger than 1 years of age, or in pregnant or breast feeding female.
11) Patient with a known allergy to FD&C Blue #1 dye.
* All exclusion criteria are determined based on information contained in "Warnings" and "Contraindications" in the Instructions for Use.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Okada |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Neurosurgery
Zip code
Address
8-1, Kawatacho Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Covidien Japan Inc.
Division name
Surgical & Energy Devices
Zip code
Address
10-2, Yoga- 4-chome Setagaya-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Covidien Japan Inc.
Institute
Department
Personal name
Funding Source
Organization
Covidien Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岩手医科大学附属病院 （岩手県）
大阪大学医学部附属病院 （大阪府）
岡山大学病院 （岡山県）
九州大学病院 （福岡県）
京都大学医学部附属病院 （京都府）
国立循環器病研究センター （大阪府）
順天堂大学医学部附属順天堂医院 （東京都）
信州大学医学部附属病院 （長野県）
千葉大学医学部附属病院 （千葉県）
東京大学医学部付属病院 （東京都）
東北大学病院 （宮城県）
徳島大学病院 （徳島県）
富山大学附属病院 （富山県）
長崎大学医学部附属病院 （長崎県）
名古屋大学医学部附属病院 （愛知県）
北海道大学病院 （北海道）
山口大学医学部附属病院 （山口県）
山梨大学医学部附属病院 （山梨県）
横浜市立大学附属病院 （神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 01 | Day |
Other
Other related information
Multi-center prospective observational study
Management information
Registered date
| 2012 | Year | 01 | Month | 26 | Day |
Last modified on
| 2013 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008394
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
