UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027166 |
|---|---|
| Receipt number | R000031129 |
| Scientific Title | The interventional trial for the test of utility of artificial pancreas on pancreas transplantation |
| Date of disclosure of the study information | 2017/04/27 |
| Last modified on | 2017/04/27 17:24:09 |
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Basic information
Public title
The interventional trial for the test of utility of artificial pancreas on pancreas transplantation
Acronym
Artificial pancreas on pancreas transplantation
Scientific Title
The interventional trial for the test of utility of artificial pancreas on pancreas transplantation
Scientific Title:Acronym
Artificial pancreas on pancreas transplantation
Region
| Japan |
Condition
Condition
Type 1 diabetes, Chronic kidney disease
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The test of utility of artificial pancreas on pancreas transplantation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Glucose tolerance accessed by OGTT one month after transplantation
Key secondary outcomes
Blood flow velocity and resistance accessed by CEUS , morbidity, Days of ICU stay, Days of hospitalization
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
use artificial pancreas for the perioperative period of the pancreas transplant
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
The pancreas transplant that is enforced in our hospital which was able to get an agreement
Key exclusion criteria
subject is otherwise considered ineligible for the study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kenmochi |
Organization
Fujita Health University Hospital
Division name
Department of Organ Transplant Surgery
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-9043
kenmochi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taihei Ito |
Organization
Fujita Health University Hospital
Division name
Department of Organ Transplant Surgery
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, JAPAN
TEL
0562-93-2380
Homepage URL
i-taihei@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University HospitalDepartment of Organ Transplant Surgery
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
藤田保健衛生大学病院（愛知県）/Fujita Health University Hospital(Aichi)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 27 | 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
| 2016 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031129
