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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007147
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute Covidien Japan Inc.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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