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

Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name