UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008945 |
|---|---|
| Receipt number | R000010487 |
| Scientific Title | A Prospective, Single-center Investigation of the Safety and Performance of the enteral feeding pump |
| Date of disclosure of the study information | 2012/09/19 |
| Last modified on | 2016/03/23 13:22:59 |
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Basic information
Public title
A Prospective, Single-center Investigation of the Safety and Performance of the enteral feeding pump
Acronym
A Prospective, Single-center Investigation of the Safety and Performance of the enteral feeding pump
Scientific Title
A Prospective, Single-center Investigation of the Safety and Performance of the enteral feeding pump
Scientific Title:Acronym
A Prospective, Single-center Investigation of the Safety and Performance of the enteral feeding pump
Region
| Japan |
Condition
Condition
Patients receiving enteral nutrition via nasogastric tube, gastric fistula, or intestinal fistula
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine and evaluate the safety and efficacy of the enteral feeding pump, Joey in patients after surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of tube clogging
Key secondary outcomes
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
Joey enteral feeding pump
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
1) Patients receiving enteral nutrition via nasogastric tube, gastric fistula, or intestinal fistula
2) 20 years old or older
3) Patients with preserved major organ function
4) Patients who have provided written informed consent for participation in the study
Key exclusion criteria
1) Patients judged unsuitable for study participation by the investigator for any other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimi Kaido |
Organization
Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery
Zip code
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University,
Institute
Department
Personal name
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
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
| 2012 | Year | 09 | Month | 19 | 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
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 15 | 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
| 2012 | Year | 09 | Month | 19 | Day |
Last modified on
| 2016 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010487
