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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013768
Receipt No. R000016071
Scientific Title Phase III study for efficacy of V-Loc 180 for laparoscopic distal gastrectomy
Date of disclosure of the study information 2014/04/21
Last modified on 2014/04/25

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Basic information
Public title Phase III study for efficacy of V-Loc 180 for laparoscopic distal gastrectomy
Acronym Phase III of V-Loc 180
Scientific Title Phase III study for efficacy of V-Loc 180 for laparoscopic distal gastrectomy
Scientific Title:Acronym Phase III of V-Loc 180
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate of efficacy of V-Loc at the time of enteral closure for laparoscopic distal gastrectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Postoperative complication
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 linear stapler
Interventions/Control_2 standard suture device
Interventions/Control_3 V-LOC 180
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
80 years-old >=
Gender Male and Female
Key inclusion criteria early gastric cancer located in the lower stomach
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 with the complication of psychiatric disorders or psychiatric symptoms, and who are judged to have difficulty participating in the study.5)Other patients who are considered not suitable for participation in this study by the physician in charge.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Uchiyama
Organization Osaka medical college
Division name General & Gastroenterological Surgery
Zip code
Address Daigaku-machi 2-7, Takatsuki City, Osaka
TEL 072-6831221
Email uchi@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Kawai
Organization Osaka medical college
Division name General & Gastroenterological Surgery
Zip code
Address Daigaku-machi 2-7, Takatsuki City, Osaka
TEL 072-6831221
Homepage URL
Email sur080@poh.osaka-med.ac.jp

Sponsor
Institute Osaka medical college
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 21 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
2014 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 22 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
2014 Year 04 Month 21 Day
Last modified on
2014 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016071

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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