UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016889 |
|---|---|
| Receipt number | R000018986 |
| Scientific Title | A study of the efficacy of endoscopic hemostasis using an detachable snare against diverticular bleeding of colon |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2018/05/27 10:41:16 |
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Basic information
Public title
A study of the efficacy of endoscopic hemostasis using an detachable snare against diverticular bleeding of colon
Acronym
The efficacy of endoscopic hemostasis using an detachable snare for diverticular bleeding of colon
Scientific Title
A study of the efficacy of endoscopic hemostasis using an detachable snare against diverticular bleeding of colon
Scientific Title:Acronym
The efficacy of endoscopic hemostasis using an detachable snare for diverticular bleeding of colon
Region
| Japan |
Condition
Condition
diverticular bleeding of colon
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of endoscopic hemostasis using an detachable snare against diverticular bleeding of colon
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rebleeding rate
Key secondary outcomes
Bleeding source identification rate
Effective rate
Complications
Hemostatic procedure time
Factor of unsuccessful
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
Ligation hemostasis by detachable snare
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with bloody stool who colon diverticulum bleeding was suspected
Key exclusion criteria
Patients with severe underlying disease
Patients with a high degree of bleeding tendency
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichinosuke Hyodo |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Gastroenterology
Zip code
Address
1-1-1Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3218
ihyodo@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Narasaka |
Organization
University of Tsukuba Hospital
Division name
Division of endoscopy
Zip code
Address
2-1-1Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3218
Homepage URL
narasaka-gi@umin.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
| 2015 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | 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
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2018 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018986
