UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047562 |
|---|---|
| Receipt number | R000050041 |
| Scientific Title | Prospective registry study of efficacy and safety on post marketing surveillance of Matsudaito for hemostasis of vascular anastomosis |
| Date of disclosure of the study information | 2022/04/22 |
| Last modified on | 2022/04/22 16:49:49 |
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Basic information
Public title
Use-results survey of Matsudaito
Acronym
Post marketing surveillance of Hydrofit
Scientific Title
Prospective registry study of efficacy and safety on post marketing surveillance of Matsudaito for hemostasis of vascular anastomosis
Scientific Title:Acronym
Prospective registry study on post marketing surveillance of Hydrofit
Region
| Japan |
Condition
Condition
Thoracic aorta aneurism or dissection
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the efficacy and safety in the actual clinical use, based on the results of this surveillance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of defects and adverse events during 1 year follow-up
Key secondary outcomes
Hemostatic effect during surgical procedure, and presence/absence of additional hemostatic procedures
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 | Behavior,custom |
Interventions/Control_1
Hemostasis with Hydrofit
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients treated with Hydrofit to stop bleeding
2 Patient registered on use-result survey of Hydrofit
Key exclusion criteria
not determined
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Amano |
Organization
Sanyo Chemical Industries, Ltd.
Division name
Biotechnology & Medical Division
Zip code
605-0995
Address
11-1, Ikkyo Nomoto-cho, Higashiyama-ku, Kyoto, Japan
TEL
075-541-6318
y.amano@sanyo-chemical.group
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Maeda |
Organization
Sanyo Chemical Industries, Ltd.
Division name
Biotechnology & Medical Division Regulatory Affairs dept.
Zip code
605-0995
Address
11-1, Ikkyo Nomoto-cho, Higashiyama-ku, Kyoto, Japan
TEL
075-541-6310
Homepage URL
h.maeda@sanyo-chemical.group
Sponsor or person
Institute
Sanyo Chemical Industries, Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
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
北海道大野記念病院、北海道大学病院、札幌心臓血管クリニック、岩手医科大学附属病院、東北大学病院、自治医科大学附属病院、群馬県立心臓血管センター、伊勢崎市民病院、埼玉石心会病院、春日部中央総合病院、上尾中央総合病院、榊原記念病院、東京医科大学病院、イムス葛飾ハートセンター、聖路加国際病院、帝京大学医学部附属病院、石心会 川崎幸病院、横浜市立大学附属市民総合医療センター、東海大学医学部附属病院、立川綜合病院、佐久総合病院、国立病院機構名古屋大学医学部附属病院、名古屋徳洲会総合病院、佐久医療センター、静岡医療センター、藤田医科大学病院、名古屋第二赤十字病院、安城更生病院、一宮市立市民病院、三重大学医学部、京都府立医科大学、京都第一赤十字病院、舞鶴共済病院附属病院附属病院、国立循環器病 兵庫県立明石医療センター、神戸大学医学部附属病院研究センター、姫路循環器病センター、神戸市立医療センター中央市民病院、天理よろづ相談所病院、和歌山県立医科大学附属病院、鳥取大学医学部附属病院「憩の家」、倉敷中央病院、九州大学病院、福岡大学病院、国立病院機構、心臓病センター、九州医療センター、済生会熊本病院、大分大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
http://www.pmda.go.jp/PmdaSearch/
Publication of results
Published
Result
URL related to results and publications
https://www.pmda.go.jp/PmdaSearch/kikiSearch/
Number of participants that the trial has enrolled
576
Results
<Efficacy verification>
95.6% of anastomotic sites showed hemostatic effect, and 66.7% of anastomotic sites didn't need additional hemostatic procedure, suggesting excellent hemostatic effect.
<Safety verification>
94 patients defects/adverse events (incidence rate:16.3%) were reported.
Without specificity on the types and occurrence/severity of the AEs, no AEs considered specific to the product.
<Summary>
Hydrofit is effective and safe, with no problems with the safety and efficacy in real use.
Results date posted
| 2021 | Year | 04 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent thoracic aorta replacement surgery
Participant flow
Patients treated with Hydrofit
Adverse events
General adverse events which are commonly observed after aortic replacement surgery
Outcome measures
Safety and efficacy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 22 | Day |
Last modified on
| 2022 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050041
