The safety of Endoscopic Sleeve Gastroplasty for Japanese obesity patients

JRCT ID: jRCTs032200049

Registered date:10/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: obesity patients with BMI more than 27kg/m2
• Date of first enrollment: 04/11/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Endoscopic Sleeve Gastroplasty will be done using an endoscopic suturing device

Outcome(s)

• Primary Outcome: A rate of adverse event associated with Endoscopic Sleeve Gastroplasty

Secondary Outcome

1) Percent of total body weight loss = (weight before ESG- weight after ESG)/ weight before ESGX100
2) A change of waist circumference
3) A change of blood biochemistry test and blood pressure
4) A change of mediations for diabetes mellitus, hyperlipidemia, and hypertension
5) A change of nutrient intake
6) A change of intestinal microbiota

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1) BMI of 27 kg/m2 or more.
2) A patient who has diabetes mellitus, hypertension, disorder of lipid metabolism, hepatic dysfunction or sleep apnea syndrome.
3) A patient who are aged of 20 years or older and 65 years or younger at giving their consent.
4) A patient who can understand this clinical trial and the informed concent can be obained with free will by the patient.
5) A patient who have already followed up for three months and can come to Jikei university l according to the planned schedule
6) A Japanese patient

Exclude criteria

Primary: depends on interview
1) A patent who can't stop antithrombotic or anticoagulant drug
2) A patient who is pregnant or who is probably pregnant
3) A patient who is nursing
4) A patient who has experience of undergoing upper abdominal surgery with possible perigastric adhesions
5) Prader-Willi syndrome
6) A patient who is evaluated as an inappropriate patient by clinical researchers

Secondary: depends on examinations
7) Serum creatinine > 1.5mg/dl
8) A patient who has malignancy
9) A patient who has active gastric ulcer
10) A patient who is/was infected by Helicobacter pylori
11) A patient who has chronic gastritis
12) A patient who has esophageal/ gastric varices
13) A patient who is evaluated as an inappropriate patient by clinical researchers

Related Information

• Primary Sponsor: Sumiyama Kazuki
• Source(s) of Monetary Support: Apollo Endosurgery