UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038899 |
|---|---|
| Receipt number | 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 12:27:42 |
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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
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
r0760ky@jichi.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044350
