Safety study of endoscopic intragastric balloon for obese patients with endocrine metabolism disease

Yamashita Taro0 sites10 target enrollmentJanuary 20, 2020

Overview

No summary available.

Registry

who.int

Start Date

January 20, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Yamashita Taro

•1\) BMI 27\.5 kg / m2 or more
•2\) Metabolic disorders (Diabetes, hypertension, dyslipidemia, obesity according to the diagnostic criteria of the Japan Diabetes Society, The Japanese Society of Internal Medicine, Japan Arteriosclerosis Disease Prevention Guidelines)
•3\) Insufficient weight control in medical treatment including diet for more than 6 months
•4\) Age 20 to 80
•5\) Performance status (PS) is 0 or 1 by ECOG criteria
•6\) The latest inspection value within 7 days before registration (may be the same day one week before registration date) satisfies all the following.
•1 white blood cell count less than 10,000 / mm3
•2 number of neutrophils more than 1,500 / mm3
•3 Hemoglobin more than 9\.0 g / dL (no blood transfusion within 7 days prior to blood collection for the test used for registration)
•4 platelet count more than 10 x 10 4 / mm 3

•1\) History of surgery on the stomach
•2\) Infections that require systemic treatment (except for viral hepatitis)
•3\) Women who are pregnant or have pregnancy possibility
•4\) Difficult to participate because it has a mental disease or symptoms that interfere with daily life.
•5\) Serious complications (heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction etc.)
•6\) In addition, research principal investigator or the research division physician judged inappropriate
•7\)Participants who have been given sufficient explanations, and with sufficient understanding and consent from the patients themselves for their participation in this study