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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034765
Receipt No. R000039648
Scientific Title Clinical study on colonic endoscopic submucosal dissection using Endosaber
Date of disclosure of the study information 2019/11/05
Last modified on 2018/11/05

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Basic information
Public title Clinical study on colonic endoscopic submucosal dissection using Endosaber
Acronym Clinical study on colonic ESD using Endosaber
Scientific Title Clinical study on colonic endoscopic submucosal dissection using Endosaber
Scientific Title:Acronym Clinical study on colonic ESD using Endosaber
Region
Japan

Condition
Condition Colorectal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical outcomes of endoscopic submucosal dissection with self-completion method using Endosaber for colorectal neoplasms.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Self-completion ESD rate without any other devices and assistance
Key secondary outcomes Procedure time, en-bloc/complete resection rate, complication rate, pathological ecvaluation

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Leions diagnosed as adenoma or adenocarcinoma by endoscopy/biopsy
Lesions within 4cm
Lesions not on the cecum
Lesions not on the folds
Lesions without submucosal ficrosis
Lesions without lymph node or distant metastasis
Patient's PS: 0 or 1
Maintained main organs function
Without dialysis
Written informed consent
Key exclusion criteria Patient's refusal
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Esaki
Organization Nihon University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 30-1, Oyaguchikami-cho Itabashi-ku, Tokyo
TEL 03-3293-8111
Email esaki_saiseikai@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Esaki
Organization Nihon University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 30-1, Oyaguchikami-cho Itabashi-ku, Tokyo
TEL 03-3293-8111
Homepage URL
Email esaki_saiseikai@yahoo.co.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization Nihon University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization 20,20

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
2019 Year 11 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 10 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ESD with self-completion method using Endosaber will be an important option if good outcomes are obtained.

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039648

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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