Benefits of Endoscopic Bariatric Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endobariatric procedure.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up
Overview
This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty \[ESG\] or transoral outlet reduction \[TORe\]) as clinically indicated, and subsequent follow up clinic visits for up to one year.
Detailed description
The purpose the research is to better understand the effects of endoscopic bariatric therapy (EBT) on the weight change, hormonal changes and changes in the quality of life parameters for patients undergoing endoscopic bariatric procedures.
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
Interventions
- Procedure Endobariatric procedure
Endoscopic sleeve gastroplasty or transoral outlet reduction
Primary outcome measures
- Changes in body weight after various endoscopic bariatric therapies [Time frame: Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure]
Secondary outcome measures (1)
- Changes in hormonal profiles after various endoscopic bariatric therapies [Time frame: Baseline/pre-procedure, 3 months, 6 months]
Eligibility criteria
Inclusion criteria
- Patients who are considering undergoing EBT for weight loss
- 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
- Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Liliana Bancila — Los Angeles
Identifiers
NCT: NCT05514288 · STUDY00002145