Safety of endoscopic intragastric balloon

JRCT ID: jRCTs042190108

Registered date:20/01/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Obesity with metabolic disease
• Date of first enrollment: 12/02/2020
• Target sample size: 10
• Study type: Interventional
• Intervention(s): None

Outcome(s)

• Primary Outcome: Safety of endoscopic intragastric balloon

Secondary Outcome

1. Changes in body composition (fat circumference, fat mass, lean mass, bone mass measured by impedance method or DXA method)
2. Transition of metabolic disease related markers
3. Changes in stool bacteria and virus flora

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

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 / dL

Exclude criteria

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

Related Information

• Primary Sponsor: Yamashita Taro
• Secondary ID(s): Nil known