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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039411
Receipt No. 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 2020/02/06

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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
Email 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
Email rinta@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2020 Year 01 Month 28 Day
Date of IRB
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
2020 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044929

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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