UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044774 |
|---|---|
| Receipt number | R000051143 |
| Scientific Title | An analysis of the function of lower gastrointestinal tract using Endoscopic pressure study integrated system (EPSIS) |
| Date of disclosure of the study information | 2021/07/06 |
| Last modified on | 2021/07/06 17:38:15 |
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Basic information
Public title
An analysis of the function of lower gastrointestinal tract using Endoscopic pressure study integrated system (EPSIS)
Acronym
An analysis of the function of lower gastrointestinal tract using Endoscopic pressure study integrated system (EPSIS)
Scientific Title
An analysis of the function of lower gastrointestinal tract using Endoscopic pressure study integrated system (EPSIS)
Scientific Title:Acronym
An analysis of the function of lower gastrointestinal tract using Endoscopic pressure study integrated system (EPSIS)
Region
| Japan |
Condition
Condition
functional gastrointestinal disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure bowel pressure over time using EPSIS, and to analyze the relationship with endoscopic and clinical findings evaluated at the same time, and to clarify the usefulness of EPSIS in the treatment of the lower gastrointestinal tract.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At the time of maximum intestinal distension
Intra-intestinal pressure (IIP) max
Intra-intestinal pressure (IIP) max at the time of maximum intestinal distension
Uphill pattern/flat pattern
Intestinal pressure waveform slope
Endoscopic findings at the time the maximum pressure was recorded
Investigate trends in each section (small bowel, cecum to ascending colon, transverse colon, descending colon, sigmoid colon, rectum).
Key secondary outcomes
Association with factors outside the intestinal tract that may affect intestinal content
Association with factors outside the intestinal tract that may affect the intestinal content: body size (height and weight BMI), history of abdominal surgery, inflammatory diseases of the abdomen, etc.
Endoscopic findings: association with factors related to intestinal wall extension (e.g., scarring of the intestine)
Intra-intestinal pressure changes when intestinal peristalsis is induced
Changes in bowel pressure before and after administration of a test drug that has an effect on bowel peristalsis
Changes in abdominal symptoms associated with pressurization (non-sedated patients)
Assess the relationship between the degree of distress and the pressure at which distress was felt using the VAS scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Carbon dioxide insufflation into the intestinal tract during colonoscopy for subjects undergoing colonoscopy (FGID patients)
Interventions/Control_2
Carbon dioxide insufflation into the intestinal tract during colonoscopy for subjects undergoing colonoscopy (other patients)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing colonoscopy at the implementing facility
Key exclusion criteria
Patients who are pregnant.
Patients with serious underlying diseases (serious respiratory disease, cardiac failure, renal failure, hepatic failure).
Patients who are considered ineligible by the investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Haruhiro |
| Middle name | |
| Last name | Inoue |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive disease center
Zip code
1358577
Address
5-1-38, Toyosu, Koto-ku, Tokyo
TEL
0362046000
haru.inoue@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Toshimori |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive disease center
Zip code
1358577
Address
5-1-38, Toyosu, Koto-ku, Tokyo
TEL
0362046000
Homepage URL
akikotoshimori@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Koto Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Koto Toyosu Hospital
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
Showa University Koto Toyosu Hospital
Address
5-1-38, Toyosu, Koto-ku, Tokyo
Tel
0362046000
th_irb@ofc.showa-u.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
| 2021 | Year | 07 | Month | 06 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051143
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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