Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-11-01
2025-09-30
Brief Summary
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Detailed Description
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The primary research procedures are:
* EBT procedure (endoscopic sleeve gastroplasty \[ESG\] or transoral outlet reduction \[TORe\])
* Behavioral intervention consisting of diet therapy, exercise therapy, and behavior modification
* Collection of blood to evaluate changes in hormonal profiles
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endoscopic sleeve gastroplasty/Transoral outlet reduction
Endobariatric procedure
Endoscopic sleeve gastroplasty or transoral outlet reduction
Interventions
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Endobariatric procedure
Endoscopic sleeve gastroplasty or transoral outlet reduction
Eligibility Criteria
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Inclusion Criteria
* Patients with a BMI \>30 kg/m2 (without obesity related comorbidities)
* Patients with a BMI \>27 kg/m2 (with obesity related comorbidities)
* Patients willing and able to comply with study requirements for follow-up
* Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight
* Individuals 18 years old or older are included
Exclusion Criteria
* Esophageal, gastric or duodenal malignancy
* Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
* Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
* Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
* General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the investigator
* Pregnant or planning to become pregnant during period of study participation
* Patient refuses or is unable to provide written informed consent
* Prior surgical or endoscopic anti-reflux procedure
* Patients who are unwilling or unable to comply with the follow-up study schedule
18 Years
75 Years
ALL
Yes
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Kenneth Park
MD, Assistant Professor of Medicine Cedars-Sinai Medical Center
Principal Investigators
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Kenneth Park, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Liliana Bancila
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Liliana Bancila
Role: primary
Other Identifiers
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STUDY00002145
Identifier Type: -
Identifier Source: org_study_id
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