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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033145
Receipt No. R000037800
Scientific Title An evaluation of the technical success rate and safety of Needle Knife Stricturotomy for re-stenosis after balloon dilation in Crohn's disease patients with bowel stenosis : A Pilot Study.
Date of disclosure of the study information 2018/07/23
Last modified on 2019/06/27

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Basic information
Public title An evaluation of the technical success rate and safety of Needle Knife Stricturotomy for re-stenosis after balloon dilation in Crohn's disease patients with bowel stenosis : A Pilot Study.
Acronym An evaluation of the technical success rate and safety of Needle Knife Stricturotomy for re-stenosis after balloon dilation in Crohn's disease patients with bowel stenosis : A Pilot Study.
Scientific Title An evaluation of the technical success rate and safety of Needle Knife Stricturotomy for re-stenosis after balloon dilation in Crohn's disease patients with bowel stenosis : A Pilot Study.
Scientific Title:Acronym An evaluation of the technical success rate and safety of Needle Knife Stricturotomy for re-stenosis after balloon dilation in Crohn's disease patients with bowel stenosis : A Pilot Study.
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the technical success rate of Needle Knife Stricturotomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Technical success rate when Needle Knife Stricturotomy is performed.
Key secondary outcomes Releasing rate of the stenosis after 4 and 24 weeks after Needle Knife Stricturotomy
Adverse events

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 Achievement of Needle Knife Stricturotomy
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
70 years-old >
Gender Male and Female
Key inclusion criteria Crohn's disease

With bowel re-stenosis which the scope can't pass after balloon dilation for bowel stenosis.

Performance Status:0-2

outpatient or inpatient
Key exclusion criteria Over 2cm lengths of stenosis.

With surgical lesion such as stenosis or abscess

With edematous stenosis, not fibrotic stenosis.

With anti-platelet agents or anti-coagulant agents which are not permitted temporally cessation.

Woman with pregnancy, possibility of pregnancy. Woman who is within 28 days after postpartum, or gives the breast to a child.

With psychiatric disorder

With severe cardiopulmonary disorder


Target sample size 5

Research contact person
Name of lead principal investigator
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, Aoba, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7171
Email rinta@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, Aoba, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7171
Homepage URL
Email rinta@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization None
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 Tohoku University Hospital Institutional Review Board
Address 1-1, Seiryo, Aoba, Sendai, 980-8574, Miyagi, Japan
Tel +81-22-728-4105
Email rinri-2@proj.med.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
2018 Year 07 Month 23 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 5
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
2018 Year 07 Month 25 Day
Date of IRB
2018 Year 07 Month 19 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2019 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 26 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037800

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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