UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041336 |
|---|---|
| Receipt number | R000047196 |
| Scientific Title | A Prospective study, using the VersaOne Fascial Closure system during abdominal wall closure at port insertion site in laparoscopic surgery |
| Date of disclosure of the study information | 2020/08/07 |
| Last modified on | 2021/02/11 18:11:04 |
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Basic information
Public title
A Prospective study, using the VersaOne Fascial Closure system during abdominal wall closure at port insertion site in laparoscopic surgery
Acronym
A Prospective study, using the VersaOne Fascial Closure system during abdominal wall closure at port insertion site in laparoscopic surgery
Scientific Title
A Prospective study, using the VersaOne Fascial Closure system during abdominal wall closure at port insertion site in laparoscopic surgery
Scientific Title:Acronym
A Prospective study, using the VersaOne Fascial Closure system during abdominal wall closure at port insertion site in laparoscopic surgery
Region
| Japan |
Condition
Condition
gastrointestinal disease
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the safety and efficacy of the VersaOne Fascial Closure system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fascial closure time of 12mm port
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Cases using a 12 mm port in cases undergoing laparoscopic surgery
2)A case in which the thickness from the skin to the peritoneum measured by CT is 30 mm or more at the planned port insertion site
3)Latest test results within 2 months prior to registration, maintaining organ function required for surgery under general anesthesia
4)Written consent has been obtained from the study participant
5)Excludes patients with a history of open surgery and previous wounds at the site of planned port insertion
6) Other cases considered inappropriate by the attending physician are excluded.
Key exclusion criteria
Patients with a history of previous laparotomy and a history of injury at the site where the port is to be inserted or other complications or treatment courses that the attending physician deems inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo Medical University Hospital
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8556
Address
nishi 16 choume minami 1 jyo Chuo-ku Sapporo
TEL
0116112111
itakemasa@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ishii |
Organization
Sapporo Medical University Hospital
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8556
Address
nishi 16 choume minami 1 jyo Chuo-ku Sapporo
TEL
0116112111
Homepage URL
masayuki-ishii@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Hospital
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
Sapporo medical university hospital institutional review board
Address
nishi 16 choume minami 1 jyo Chuo-ku Sapporo
Tel
0116112111
ji-rskk@sapmed.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
| 2020 | Year | 08 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2020 | Year | 08 | Month | 06 | Day |
Last modified on
| 2021 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047196
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
