The safety of Endoscopic Sleeve Gastroplasty for Japanese obesity patients

Phase 1

Recruiting

• Conditions: obesity patients with BMI more than 27kg/m2; Obesity, Endoscopic therapy, Bariatric surgery

• Registration Number: JPRN-jRCTs032200049
• Lead Sponsor: Sumiyama Kazuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A rate of adverse event associated with Endoscopic Sleeve Gastroplasty

Secondary Outcome Measures

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