UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intragastric injection of botulinum toxin A for the treatment of obesity
Title of the study (Brief title)	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	Jin Kan Sai
Organization	Juntendo University Hospital
Division name	Department of Gastroenterology
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL	03-3813-3111(70227)
Email	jinkans@juntendo.ac.jp

Public contact
Name of contact person	Ryo Kanazawa
Organization	Juntendo University Hospital
Division name	Department of Gastroenterology
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL	03-3813-3111(70226)
Homepage URL
Email	rkanaza@juntendo.ac.jp

Sponsor
Institute	Juntendo University Hospital Department of Gastroenterology
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024149