UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020931 |
|---|---|
| Receipt number | R000024149 |
| Scientific Title | Intragastric injection of botulinum toxin A for the treatment of obesity |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2017/12/20 15:20:30 |
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Basic information
Public title
Intragastric injection of botulinum toxin A for the treatment of obesity
Acronym
Intragastric injection of botulinum toxin A for the treatment of obesity
Scientific Title
Intragastric injection of botulinum toxin A for the treatment of obesity
Scientific Title:Acronym
Intragastric injection of botulinum toxin A for the treatment of obesity
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacty and safety of intragastric injection of botulinum toxin A for the treatment of obesity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight loss after 24 weeks
Key secondary outcomes
Incidence of complications
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 | Maneuver |
Interventions/Control_1
Injections were performed via 25G EUS needle under real-time EUS guidance,targeting the gastric muscularis propria by 20 U in ten places
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with more than BMI30
Key exclusion criteria
1, myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis
2, Patient with the high breathing disorder
3, Pregnant woman, woman with the possibility of the pregnancy,nursing girl
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jin Kan Sai |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111(70227)
jinkans@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Kanazawa |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111(70226)
Homepage URL
rkanaza@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Department of Gastroenterology
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
| 2016 | Year | 03 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024149
