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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038899
Receipt No. R000044350
Scientific Title Study on safety for endoscopy and treatment by measuring intestinal pressure
Date of disclosure of the study information 2019/12/16
Last modified on 2019/12/16

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Basic information
Public title Study on safety for endoscopy and treatment by measuring intestinal pressure
Acronym Study on safety for endoscopy and treatment by measuring intestinal pressure
Scientific Title Study on safety for endoscopy and treatment by measuring intestinal pressure
Scientific Title:Acronym Study on safety for endoscopy and treatment by measuring intestinal pressure
Region
Japan

Condition
Condition The patient with small intestine disease and bilio pancreatic disease underwent ERCP, double balloon enteroscopy and double balloon assisted ERCP
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By measuring the intestinal pressure at the distal end of the endoscope, the safety of examination and treatment for the small intestine and postoperative reconstructed intestinal tract using double balloon endoscope is clarified.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the safety of examination and treatment for the small intestine and postoperative reconstructed intestinal tract using double balloon endoscope
Key secondary outcomes

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
75 years-old >=
Gender Male and Female
Key inclusion criteria The patients underwent ERCP, double balloon enteroscopy, and double balloon assisted ERCP in Jichi Medical Univ.
Key exclusion criteria The patients with acute abdominal condition
The patients with acute severe inflammation
Pregnant patients
The patients with poor general condition
The patients taking anticoagulant
The patients with stenosis in the small intestine
Patients judged to be inappropriate by the doctor in charge
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hironori
Middle name
Last name Yamamoto
Organization Jichi Medical University
Division name Department of Gastroenterology, Jichi Medical University
Zip code 329-0498
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL 0285-58-7348
Email yamamoto@jichi.ac.jp

Public contact
Name of contact person
1st name Kensuke
Middle name
Last name yokoyama
Organization Jichi Medical University
Division name Department of Gastroenterology
Zip code 329-0498
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL 0285-58-7348
Homepage URL
Email r0760ky@jichi.ac.jp

Sponsor
Institute Department of Gastroenterology, Jichi Medical University
Institute
Department

Funding Source
Organization FUJIFILM
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 Bioethics committee for clinical research A, Jichi medical university hospital
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
Tel 0285-58-7348
Email rinri@jichi.ac.jp

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 12 Month 16 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 03 Month 22 Day
Date of IRB
2018 Year 03 Month 22 Day
Anticipated trial start date
2018 Year 03 Month 22 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clarify the safety of inspection and treatment of the small intestine and postoperative reconstructed intestinal tract by measuring the pressure in the intestinal tract at the distal end of the endoscope

Management information
Registered date
2019 Year 12 Month 16 Day
Last modified on
2019 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044350

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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