UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043832 |
|---|---|
| Receipt number | R000050025 |
| Scientific Title | Histological damage to the nerve tissue by lateral spread steam from energy devices |
| Date of disclosure of the study information | 2021/04/05 |
| Last modified on | 2021/10/04 18:27:21 |
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Basic information
Public title
Histological damage to the nerve tissue by lateral spread steam from energy devices
Acronym
Histological damage to the nerve tissue by lateral spread steam from energy devices
Scientific Title
Histological damage to the nerve tissue by lateral spread steam from energy devices
Scientific Title:Acronym
Histological damage to the nerve tissue by lateral spread steam from energy devices
Region
| Japan |
Condition
Condition
Abdominal surgery
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the thermal spread of jet steam produced by advanced energy devices its histologic damage to the tissue
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of histological thermal damage
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Use only porcine tissue
Key exclusion criteria
Use only porcine tissue
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kiyozumi |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo, Japan
TEL
0335200111
y-kiyozumi@kumachu.gr.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kiyozumi |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
y-kiyozumi@kumachu.gr.jp
Sponsor or person
Institute
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address
3-8-31, Ariake, Koto, Tokyo, Japan
Tel
03-3520-0111
y-kiyozumi@kumachu.gr.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
| 2021 | Year | 04 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to measure the temperature of the steam by energy devises, to pathologically evaluate the effects on the tissues, and to define a safe margin for surgery.
Management information
Registered date
| 2021 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050025
