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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035224
Receipt No. R000040140
Scientific Title Prospective Multicenter Feasibility Study of HANAROSTENT Naturfit Colonic Stent
Date of disclosure of the study information 2018/12/12
Last modified on 2019/03/17

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Basic information
Public title Prospective Multicenter Feasibility Study of HANAROSTENT Naturfit Colonic Stent
Acronym HANAROSTENT Naturfit Colonic Stent prospective feasibility study
Scientific Title Prospective Multicenter Feasibility Study of HANAROSTENT Naturfit Colonic Stent
Scientific Title:Acronym HANAROSTENT Naturfit Colonic Stent prospective feasibility study
Region
Japan

Condition
Condition malignant colo-rectal strictures
Classification by specialty
Gastroenterology Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this registry is to compile clinical experience of use of the HANAROSTENT Naturfit 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 Not applicable

Assessment
Primary outcomes Clinical Efficacy of HANAROSTENT Naturfit Colonic Stent, associated to Obstruction Relief and Permeability
Key secondary outcomes Additional data related to the procedure and the product: Technical success, Complications, Survival, Palliation vs Bridge to Surgery

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 Patients requiring palliative treatment of colorectal strictures produced by malignant neoplasms.
Only patients with no previous colonic stenting will be included in the registry.
Key exclusion criteria Patients contraindicated will include those presenting
- enteral ischemia
- benign stricture
- suspected or impending perforation
- intrabdominal abscess / perforation
- strictures that do not allow passage of a guide wire
- patients for whom endoscopic techniques are contraindicated
- any use other than those specifically outlined under indications of use
(inclusion)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shuji
Middle name
Last name Saito
Organization Yokohama Shin-Midori General Hospital
Division name Division of Surgery, Gastrointestinal Center
Zip code 226-0025
Address 1726-7 Tokaichiba-cho, Midori-ku, Yokohama
TEL 045-984-2400
Email shusaito@jb3.so-net.ne.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Otsuka
Organization Yokohama Shin-Midori General Hospital
Division name Division of Surgery, Gastrointestinal Center
Zip code 226-0025
Address 1726-7 Tokaichiba-cho, Midori-ku, Yokohama
TEL 045-984-2400
Homepage URL http://colon-stent.com/
Email rotsuka7791@gmail.com

Sponsor
Institute Colonic Stent Safe Procedure Research Group
Institute
Department

Funding Source
Organization Colonic Stent Safe Procedure Research Group
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 Yokohama Shin-Midori General Hospital,IRB
Address 1726-7 Tokaichiba-cho, Midori-ku, Yokohama
Tel 045-984-2400
Email nakayama@shinmidori.com

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 12 Month 12 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 10 Month 31 Day
Date of IRB
2018 Year 10 Month 31 Day
Anticipated trial start date
2019 Year 02 Month 24 Day
Last follow-up date
2023 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 2018 Dec. Planning to start

Management information
Registered date
2018 Year 12 Month 11 Day
Last modified on
2019 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040140

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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