UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032044 |
|---|---|
| Receipt number | R000036463 |
| Scientific Title | Colonic Stent "JLL" prospective feasibility study |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/03/27 20:23:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Colonic Stent "JLL" prospective feasibility study
Acronym
Colonic Stent "JLL" prospective feasibility study
Scientific Title
Colonic Stent "JLL" prospective feasibility study
Scientific Title:Acronym
Colonic Stent "JLL" prospective feasibility study
Region
| Japan |
Condition
Condition
Colo rectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this registry 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 efficacy of colon stent
1 Clinical Success Rate for Cancellation of Major Intestinal Obstruction
2 Number of clinically successful cases / registered number
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
| Device,equipment |
Interventions/Control_1
Treatment of malignant colo-rectal obstruction with Colonic Stent,5 year observation period
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
| 18 | years-old | <= |
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.
Patient who has never received a colon stenting procedure.
Key exclusion criteria
Intestinal ischemia
Suspicion or impending perforation
Intraperitoneal abscess / perforation
Patients who can not apply endoscopic procedures
Usage not applicable to the specific description of use (registration) adaptation
When the patient does not agree to the registration
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Isayama |
Organization
Juntendo Univ.
Division name
Gastroenterology
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
hritsu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Ritsuno |
Organization
University
Division name
Gastroenterology
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
hritsu@jutendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
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 | 04 | Month | 01 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 01 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036463
