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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034048
Receipt No. R000038811
Scientific Title Evaluation of usefulness of GIF-2TQ260M in endoscopic submucosal dissection for gastric cancer.
Date of disclosure of the study information 2018/09/05
Last modified on 2019/03/10

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Basic information
Public title Evaluation of usefulness of GIF-2TQ260M in endoscopic submucosal dissection for gastric cancer.
Acronym Evaluation of GIF-2TQ260M in ESD for gastric cancer.
Scientific Title Evaluation of usefulness of GIF-2TQ260M in endoscopic submucosal dissection for gastric cancer.
Scientific Title:Acronym Evaluation of GIF-2TQ260M in ESD for gastric cancer.
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of endoscopic submucosal dissection using the GIF-2TQ260M for gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes procedure time
Key secondary outcomes accident occurrence rate

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 GIF-2TQ260M
Interventions/Control_2 other scopes
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
95 years-old >
Gender Male and Female
Key inclusion criteria 1. Diagnosed with gastric cancer.
2. The absolute indication and expanded indications in the Gastric Cancer Treatment Guidelines.
3. one leision
4. Tumor location upper or middle
5. PS 0 or 1 or2




Key exclusion criteria a pregnant woman
residual stomach cancer
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Hamada
Organization Southern Tohoku general hospital
Division name Gastroenterology
Zip code
Address 7-115, Yatsuyamada, Koriyama-shi
TEL 0249345322
Email koichi.hamada@mt.strins.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Hamada
Organization Southern Tohoku general hospital
Division name Gastroenterology
Zip code
Address 7-115, Yatsuyamada, Koriyama-shi
TEL 0249345322
Homepage URL
Email koichi.hamada@mt.strins.or.jp

Sponsor
Institute Southern Tohoku general hospital
Institute
Department

Funding Source
Organization non
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
2018 Year 09 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 06 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
2018 Year 09 Month 05 Day
Last modified on
2019 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038811

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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