UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009712 |
|---|---|
| Receipt number | R000011368 |
| Scientific Title | Study on the safety and efficacy of the treatment of polidocanol injection for vascular lesions in the small bowel. |
| Date of disclosure of the study information | 2013/01/07 |
| Last modified on | 2019/01/12 10:59:05 |
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Basic information
Public title
Study on the safety and efficacy of the treatment of polidocanol injection for vascular lesions in the small bowel.
Acronym
Study on the safety and efficacy of polidocanol injection
Scientific Title
Study on the safety and efficacy of the treatment of polidocanol injection for vascular lesions in the small bowel.
Scientific Title:Acronym
Study on the safety and efficacy of polidocanol injection
Region
| Japan |
Condition
Condition
Vascular lesions in the small bowel
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of polidocanol injection for the treatment of vascular lesions in the small bowel
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complication rate
Changes in hemoglobin concentration before and after polidocanol injection
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
| Medicine |
Interventions/Control_1
Polidocanol injection for the treatment of vascular lesions in the small bowel
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 comfirmed vascular lesion in the small bowel and having at least 1 of following conditions; overt gastrointestinal bleeding, iron deficient anemia or positive fecal occult blood test.
Key exclusion criteria
1. Patients with intestinal perforation
2. Patients with bleeding tendency
3. Patients administering anti conaglant drugs
4. Patients with severe hepatic diseases
5. Patients with severe renal diseases
6. Patients with severe respiratory diseases
7. Patients with severe cardiac diseases
8. Pregnant or feeding women
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
+81338155411
yamada-a@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuo Yamada |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
+81338155411
Homepage URL
yamada-a@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
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
| 2013 | Year | 01 | Month | 07 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | 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
| 2013 | Year | 01 | Month | 07 | Day |
Last modified on
| 2019 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011368
