RECRUITINGINTERVENTIONAL
Benefits of Endoscopic Bariatric Procedures
Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
- Prior surgical or endoscopic anti-reflux procedure
- Patients who are unwilling or unable to comply with the follow-up study schedule
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
Endobariatric procedure
Endoscopic sleeve gastroplasty or transoral outlet reduction
Locations (1)
Liliana Bancila
Los Angeles, California, United States