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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034848
Receipt No. R000039737
Scientific Title Niti-s colonic MD type stent prospective feasibility study
Date of disclosure of the study information 2018/11/10
Last modified on 2018/11/10

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Basic information
Public title Niti-s colonic MD type stent prospective feasibility study
Acronym Colonic stent "MD type" prospective feasibility study
Scientific Title Niti-s colonic MD type stent prospective feasibility study
Scientific Title:Acronym Colonic stent "MD type" prospective feasibility study
Region
Japan

Condition
Condition Colo-rectal Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This registy's objective is to compile clinical experience of use of the Colonic Stent for the treatment of malignant colo-rectal strictures.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical success rate of the colonic stenting
Key secondary outcomes

Base
Study type Observational

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Preoperative treatment of colorectal obstruction caused by malignant neoplasms BTS and patients requiring palliative treatment.
Patients who has never received a colonic stenting procedure.
Key exclusion criteria Intestinal ischemia
Suspicion or impending perforation
Intraperitoneal sbscess / perforation
Patients who can not apply endoscopic procedures
Patients who have severe organ disorder
Patients who have been registered in this study
Patients who were judged not eligible for participation in this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Kuwai
Organization National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Division name Gastroenterology
Zip code
Address 3-1 Aoyama-cho, Kure, Hiroshima
TEL 0823-22-3111
Email kuwait@kure-nh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuzuru Tamaru
Organization National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Division name Gastroenterology
Zip code
Address 3-1 Aoyama-cho, Kure, Hiroshima
TEL 0823-22-3111
Homepage URL
Email tamaruy@kure-nh.go.jp

Sponsor
Institute National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Institute
Department

Funding Source
Organization National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 11 Month 10 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
2018 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study about the feasibility of Niti-s colonic MD type stent
This is a single arm study.
The target objective is preoperative treatment of colorectal obstruction caused by malignant neoplasms BTS and patients requiring palliative treatment.

Management information
Registered date
2018 Year 11 Month 10 Day
Last modified on
2018 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039737

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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