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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032956
Receipt No. R000037571
Official scientific title of the study Novel material magnetic-anchor-guided submucosal dissection for gastrointestinal cancer.
Date of disclosure of the study information 2018/06/13
Last modified on 2018/06/12

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Basic information
Official scientific title of the study Novel material magnetic-anchor-guided submucosal dissection for gastrointestinal cancer.
Title of the study (Brief title) Novel material magnetic-anchor-guided submucosal dissection
Region
Japan

Condition
Condition early gastrointestinal (esophagus, stomach, duodenum, colon) cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate feasibility and safety of the novel magnetic-anchor-guided(MAG)ESD for early gastrointestinal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes After ESD, an endoscopist evaluate the feasibility of traction with good visualization
Key secondary outcomes procedure time, complications, en-bloc resection rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 After circumferential muosal cutting, small stainless weight connecting thread microforceps is placed at the mucosal edge. The submucosal dissection by suitable traction using external magnnet placed outside the patient.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Early gastrointestinal tumors suitable for ESD. Cases with written and oral informed consent are included.
Key exclusion criteria Cases with severe complications are excluded. The patients with chemical fiber allergy. The patients with a cardiac pacemaker or implantable cardioverter defibrillator.
Target sample size 100

Research contact person
Name of lead principal investigator Hattori Masashi
Organization Mediacl corporation Yamashita Hospital
Division name Gastroenterology
Address 1-3-5, Nakamachi, Ichinomiya
TEL 0586-45-4511
Email m.hattori@yamashita.or.jp

Public contact
Name of contact person Matsuzaki Ippei
Organization Mediacl corporation Yamashita Hospital
Division name Gastroenterology
Address 1-3-5, Nakamachi, Ichinomiya
TEL 0586-45-4511
Homepage URL
Email imatsu@med.nagoya-u.ac.jp

Sponsor
Institute Mediacl corporation Yamashita Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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 06 Month 13 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 12 Day
Last modified on
2018 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037571

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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