UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039411 |
|---|---|
| Receipt number | R000044929 |
| Scientific Title | Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study |
| Date of disclosure of the study information | 2020/02/07 |
| Last modified on | 2022/02/07 16:17:33 |
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Basic information
Public title
Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study
Acronym
Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study
Scientific Title
Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study
Scientific Title:Acronym
Endoscopic Radial Incision and Cutting for benign lower intestinal stenosis: A multicenter study
Region
| Japan |
Condition
Condition
benign lower intestinal stenosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effectiveness of endoscopic radial incision and cutting (RIC) for benign lower intestinal stenosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patency rates at 52 weeks after RIC
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
RIC:Radial Incision and Cutting
1day.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
benign lower intestinal stenosis through which a scope can't pass
Key exclusion criteria
Over 2cm lengths of stenosis.
With surgical lesion such as stenosis or abscess
With edematous stenosis, not fibrotic stenosis.
With malignant stenosis.
Woman with pregnancy, possibility of pregnancy. Woman who is within 28 days after postpartum.
With psychiatric disorder
With severe cardiopulmonary disorder
The patients who the doctor judged as inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Shiga |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7171
shiga@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Rintaro |
| Middle name | |
| Last name | Moroi |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7171
Homepage URL
rinta@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Ethics Committee Tohoku University Hospital
Address
1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
| 2020 | Year | 02 | Month | 07 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 06 | Day |
Last modified on
| 2022 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044929
