UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038429 |
|---|---|
| Receipt number | R000043790 |
| Scientific Title | Efficacy of FloSeal in endonasal endoscopic approach |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2019/10/29 17:45:35 |
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Basic information
Public title
Efficacy of FloSeal in endonasal endoscopic approach
Acronym
Efficacy of FloSeal in endonasal endoscopic approach
Scientific Title
Efficacy of FloSeal in endonasal endoscopic approach
Scientific Title:Acronym
Efficacy of FloSeal in endonasal endoscopic approach
Region
| Japan |
Condition
Condition
Cases who are treated via endonasal endoscopic approach at department of neurosurgery
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of FloSeal in brain tumor resection will be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of FloSeal to stop bleeding
The bleeding would be classified in 4 grades. (1.Mild 2. Moderate 3. Sever 4. Life-threatening)
Succeed of hemostasis or not would be evaluated after applying FloSeal.
Key secondary outcomes
all the events occur during hospital stay after surgery.(maximum of 14 days)
imaging
lab data
operative complications
data of operation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
After treatment, we would apply FloSeal at the point of bleeding which was difficult to stop with other methods.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients will undergo endonasal endoscopic surgery, who is thought to be used FloSeal.
Key exclusion criteria
Who has allergy to bovine protein.
Who has infection at the surgical field.
The tumor is in the eye ball
Who has coagulopathy
Pregnant patient
Who is diagnosed with Hypofibrinogenaemia
Who the surgeons thought that it is not appropriate to use FloSeal.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | of |
| Last name | Toda |
Organization
Keio University School of Medicine
Division name
Department of Neurosurgery
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-5363-3808
todam@keio.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | Medicine |
| Last name | Toda |
Organization
Keio University School of Medicine
Division name
Department of Neurosurgery
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-5363-3808
Homepage URL
todam@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Baxter
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
Keio University School of Medicine
Address
35 Shinanomachi Shinjuku-ku Tokyo
Tel
03-3353-1211
keio@esct.bvits.com
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043790
| 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 |
