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

Yamashita Taro0 个研究点目标入组 10 人开始时间: 2020年1月20日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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
•5 Total bilirubin less than 1.5 mg / dL
•6 creatinine less than 2 mg / d

•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

发起方

Yamashita Taro