UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044382 |
|---|---|
| Receipt number | R000050453 |
| Scientific Title | Single-center, prospective, interventional clinical research to analyze mucosal permeability of endoscopic biopsy specimens by Ussing chamber experiment |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2023/08/07 14:28:45 |
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Basic information
Public title
A clinical research to analyze mucosal permeability of endoscopic biopsy specimens by Ussing chamber experiment
Acronym
A clinical research to analyze mucosal permeability of endoscopic biopsy specimens by Ussing chamber experiment
Scientific Title
Single-center, prospective, interventional clinical research to analyze mucosal permeability of endoscopic biopsy specimens by Ussing chamber experiment
Scientific Title:Acronym
Single-center, prospective, interventional clinical research to analyze mucosal permeability of endoscopic biopsy specimens by Ussing chamber experiment
Region
| Japan |
Condition
Condition
Diseases related to Increased mucosal permeability
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will evaluate the membrane permeability of mucosal tissues obtained from biopsies during gastrointestinal endoscopy using an Ussing chamber experiment.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
It is the short-circuit current value of the mucosal biopsy specimen using the Ussing chamber experiment.
Key secondary outcomes
Analyze the relationship between disease activity and prognosis (response to treatment), treatment details, and pathological evaluation and short circuit current values.
Base
Study type
Others,meta-analysis etc
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing gastrointestinal endoscopy at Chiba University Hospital.
2. Age 16 years or older.
3) Patients who have received sufficient explanation and understanding of the study and have given their free written consent to participate in the study.
Key exclusion criteria
1. Pregnancy.
2. Patients who have platelet and coagulation factor dysfunction and are considered to be at high risk of bleeding from mucosal biopsy.
3. Patients who are taking two or more antithrombotic agents or warfarin whose PT-INR is prolonged beyond the therapeutic range.
4. Patients who are deemed ineligible for participation in the study by the investigators and sub-investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | naoya |
| Middle name | |
| Last name | kato |
Organization
Chiba university
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku,Chiba-shi,Chiba
TEL
+810432227171
shiratori.wataru@chiba-u.jp
Public contact
Name of contact person
| 1st name | wataru |
| Middle name | |
| Last name | shiratori |
Organization
Chiba university
Division name
gastroenterology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku,Chiba-shi,Chiba
TEL
08066531290
Homepage URL
shiratori.wataru@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Self-adjustment
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
Chiba university
Address
1-8-1 Inohana, Chuo-ku,Chiba-shi,Chiba
Tel
+810432227171
shiratori.wataru@chiba-u.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 | 05 | Month | 31 | 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
52
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
| 2021 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 09 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Patients undergoing gastrointestinal endoscopy at Chiba University Hospital.
Management information
Registered date
| 2021 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050453
