UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015844 |
|---|---|
| Receipt number | R000018441 |
| Scientific Title | Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device. |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2019/07/30 11:17:57 |
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Basic information
Public title
Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.
Acronym
Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.
Scientific Title
Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.
Scientific Title:Acronym
Prospective intervention study to evaluate safety and effectiveness of newly developed silicon made drain fixing device.
Region
| Japan |
Condition
Condition
Patients who will have surgery in general surgery department.
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and effectiveness of silicon made newly developed drain fixing device.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety (complication due to the use of newly developed drain fixing device, troubles with drain such as occlusion)
Effectiveness (the pain caused by fixing the drain)
Key secondary outcomes
Base
Study type
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 | Maneuver |
Interventions/Control_1
To evaluate safety and effectiveness of silicon made newly developed drain fixing device for the patients having surgery in general surgery department.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who are scheduled to have surgery in general surgery department.
2) Patients who will use 19Fr silicon drain for surgery.
3) Patients with over 20 years old, and below 90 years old.
4) PS 0 or 1.
5) Provided with written informed conscent.
Key exclusion criteria
1) Patients with infection or dermatitis on the drain insertion site.
2) Patients with mental disease who may have risk of self removal of the drain.
3) Patients with diabetes mellitus under insulin therapy, or under dialysis, or patients with immune deficiency.
4) Patients with severe obesity or emaciation.
5) Patients who doctor thinks inappropriate to participate in the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Norihito |
| Middle name | |
| Last name | Wada |
Organization
Keio University, School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
nori-kkr@umin.ac.jp
Public contact
Name of contact person
| 1st name | Norihito |
| Middle name | |
| Last name | Wada |
Organization
Keio University, School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
nori-kkr@umin.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 05 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2015 | 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
| 2014 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018441
