UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005521 |
|---|---|
| Receipt number | R000006523 |
| Scientific Title | Efficacy of BioEnterics Intragastric Balloon System for the treatment of morbid obesity |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2011/04/27 20:01:40 |
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Basic information
Public title
Efficacy of BioEnterics Intragastric Balloon System for the treatment of morbid obesity
Acronym
Intragastric balloon therapy for morbid obesity
Scientific Title
Efficacy of BioEnterics Intragastric Balloon System for the treatment of morbid obesity
Scientific Title:Acronym
Intragastric balloon therapy for morbid obesity
Region
| Japan |
Condition
Condition
Morbid obesity
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of BioEnterics Intragastric Balloon System for the treatment of morbiod obesity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Weight reduction induced by intragastric balloon therapy
Key secondary outcomes
Changes in body composition, metabolic function, oxidative stress markers, and hepatic steatosis
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
| Other |
Interventions/Control_1
Intragastric balloon therapy
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Morbid obese subjects resistant to long-term (more than 6 months) medical treatments, such as diet, exercise, and behavior.
2.Morbid obese subjects in which the complications associted with obesity can be expected to improve by weight reduction.
3.Morbid obese subjects who can be followed up for at least 6 months after the start of intragastric balloon therapy.
4.Morbid obese subjects in which no abnormal lesions are found by upper alimentary tract endoscopy.
Key exclusion criteria
1.Morbid obese subjects with severe heart and lung disorders.
2.Morbid obese subjects with esophageal hiatus hernia.
3.Morbid obese subjects with inflammatory disorders in the alimentary tracts.
4.Morbid obese subjects with bleeding tendency.
5.Morbid obese subjects during pregnancy and those nursing a baby.
6.Morbid obese subjects who cannnot understand the meaning of intragastric balloon therapy and continue the therapy.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Shoda |
Organization
University of Tsukuba
Division name
Gastroenterology and Hepatology
Zip code
Address
2-1-1 Amakubo, tsukuba-shi, Ibaraki
TEL
029-853-3900
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Shoda |
Organization
University of Tsukuba Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
2-1-1 Amakubo, tsukuba-shi, Ibaraki
TEL
029-853-3900
Homepage URL
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
The affiliated hospitals of University of Tsukuba Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
筑波大学病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | 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
| 2011 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 27 | Day |
Last modified on
| 2011 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006523
