UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026505 |
|---|---|
| Receipt number | R000030440 |
| Scientific Title | PROspective Observational trial For substitute endoLEAK marker |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/03/13 07:25:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
PROspective Observational trial For substitute endoLEAK marker
Acronym
PROOF-LEAK
Scientific Title
PROspective Observational trial For substitute endoLEAK marker
Scientific Title:Acronym
PROOF-LEAK
Region
| Japan |
Condition
Condition
Aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of new endoleak marker for endoleak after stentgraft
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Endoleak
Key secondary outcomes
mortality , morbidity, secondary intervention
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) Obtaining informed consent
2) the patient with aortic aneurysm
Key exclusion criteria
1) emergency operation
2) infection of HIV/HBV/HCV
3) contrast media allergy
4) CKD grade 3b, 4
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eisaku |
| Middle name | |
| Last name | Ito |
Organization
The Jikei University Kashiwa Hospital
Division name
Division of Vascular Surgery
Zip code
277-0004
Address
163-1, Kashiwashita, Kashiwa-city, Chiba, 277-0004, Japan
TEL
04-7163-1111
i_eisaku_ukasie@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Eisaku |
| Middle name | |
| Last name | Ito |
Organization
The Jikei University Kashiwa Hospital
Division name
Division of Vascular Surgery
Zip code
277-0004
Address
163-1, Kashiwashita, Kashiwa-city, Chiba, 277-0004, Japan
TEL
04-7163-1111
Homepage URL
i_eisaku_ukasie@yahoo.co.jp
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
The Jikei University Kashiwa Hospital
Address
163-1, Kashiwashita, Kashiwa-city, Chiba, 277-0004, Japan
Tel
04-7163-1111
i_eisaku_ukasie@yahoo.co.jp
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
東京慈恵会医科大学附属柏病院(千葉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
0
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
Terminated
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 03 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030440
