UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008365 |
|---|---|
| Receipt number | R000009806 |
| Scientific Title | A Prospective, Single-center Investigation of the Performance of the V-Loc 180 in a Gastrectomy for Gastric Cancer |
| Date of disclosure of the study information | 2012/07/06 |
| Last modified on | 2014/03/03 10:23:17 |
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Basic information
Public title
A Prospective, Single-center Investigation of the Performance of the V-Loc 180 in a Gastrectomy for Gastric Cancer
Acronym
A Prospective, Single-center Investigation of the Performance of the V-Loc 180 in a Gastrectomy for Gastric Cancer
Scientific Title
A Prospective, Single-center Investigation of the Performance of the V-Loc 180 in a Gastrectomy for Gastric Cancer
Scientific Title:Acronym
A Prospective, Single-center Investigation of the Performance of the V-Loc 180 in a Gastrectomy for Gastric Cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the performance of the barbed suture V-Loc180 for closure of the access opening to create an intracorporeal anastomosis using a stapler after laparoscopic gastrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative leak at the site where V-Loc180 was applied
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are 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
V-Loc 180
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) Reconstruction is scheduled by functional end-to-end anastomosis or side-to-side anastomosis using a stapler in laparoscopic gastrectomy.
2) Age: 20 years or older.
3) No past history of surgery to the upper abdomen except laparoscopic cholecystectomy.
4) Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) of either 0 or 1.
5) The functions of the major organs are maintained.
6) Informed consent to participate in the study is obtained from the patient him/herself in writing.
Key exclusion criteria
1) Women who are pregnant/possibly pregnant or breastfeeding.
2) Patients who are continuing to use a systemic steroid preparation (oral or intravenous).
3) Patients with the complication of poorly controlled diabetes mellitus (HbA1C>8.0).
4) Patients who are allergic to nickel chrome (as specified in the package insert).
5) Patients with the complication of psychiatric disorders or psychiatric symptoms, and who are judged to have difficulty participating in the study.
6) Other patients who are considered not suitable for participation in this study by the physician in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Uchiyama |
Organization
Osaka Medical College
Division name
Department of General and Gastrointestinal Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, 569-8686
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sang-woong Lee |
Organization
Osaka Medical College
Division name
Department of General and Gastrointestinal Surgery
Zip code
Address
TEL
072-683-1221
Homepage URL
Sponsor or person
Institute
Department of General and Gastrointestinal Surgery, Osaka Medical College
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 | 07 | Month | 06 | 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
| 2012 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2014 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009806
