Clinical trial NCT05514288: Benefits of Endoscopic Bariatric Procedures
Official title: Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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

Primary outcomes:
measure: Changes in body weight after various endoscopic bariatric therapies
timeFrame: Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure
Secondary outcomes:
measure: Changes in hormonal profiles after various endoscopic bariatric therapies
timeFrame: Baseline/pre-procedure, 3 months, 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Liliana Bancila
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Kenneth Park, MD
role: PRINCIPAL_INVESTIGATOR
References: