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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017074
Receipt No. R000019769
Scientific Title Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Date of disclosure of the study information 2015/04/10
Last modified on 2017/09/19

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Basic information
Public title Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Acronym Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Scientific Title Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Scientific Title:Acronym Randomized Controlled Clinical Trial for Endoscopic Submucosal Dissection by Hook Knife with Water Jet Function.
Region
Japan

Condition
Condition Gastric or Esophageal Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of Hook knife with water jet function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The insertion number of injection needle per resected area.
Key secondary outcomes Procedure duration of ESD per resected area (from injection to the end of dissection)
The number and amount of the injection from mucosa by injection needle per resected area
The number and amount of the injection to submucosal layer by injection needle per resected area
The number and amount of the injection from mucosa by Hook knife with water jet function per resected area
The number and amount of the injection to submucosal layer by Hook knife with water jet function per resected area

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Hook Knife
Interventions/Control_2 Hook Knife with Water Jet Function
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) Gastric or esophageal cancer which has indication of endoscopic submucosal dissection.
2) Written and signed consent for trial participation must be obtained from the patient.
Key exclusion criteria 1) Prior radiotherapy from mediastinum to upper abdomen.
2) The subject judged as without eligibility for the safety of this study by lead principal investigator or contact doctor.
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tsuneo Oyama
Organization Saku Central Hospital Advanced Care Center
Division name Department of Endoscopy
Zip code
Address 3400-28 Nakagomi, Saku, JAPAN
TEL 0267-62-8181
Email oyama@coral.ocn.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Akiko Takahashi
Organization Saku Central Hospital Advanced Care Center
Division name Department of Endoscopy
Zip code
Address 3400-28 Nakagomi, Saku, JAPAN
TEL 0267-62-8181
Homepage URL
Email ctroffice@sakuhp.or.jp

Sponsor
Institute Saku Central Hospital Advanced Care Center
Institute
Department

Funding Source
Organization Saku Central Hospital Advanced Care Center
Organization
Division
Category of Funding Organization Self funding
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 佐久総合病院佐久医療センター(長野県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 11 Month 28 Day
Date analysis concluded
2016 Year 09 Month 13 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 08 Day
Last modified on
2017 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019769

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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