UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035224 |
|---|---|
| Receipt number | 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 11:49:42 |
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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
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/
rotsuka7791@gmail.com
Sponsor or person
Institute
Colonic Stent Safe Procedure Research Group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
