JPRN-jRCTs032200049RecruitingPhase 1
Endoscopic Sleeve Gastroplasty for Japanese obesity patients using single channel endoscopic suturing device (Overstitch SxTM): a single-arm exploratory trial for patient safety
Sumiyama Kazuki0 sites20 target enrollmentStarted: June 10, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 65age old (—)
- Sex
- All
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
Investigators
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