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NCT Number: NCT05514288

Benefits of Endoscopic Bariatric Procedures

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liliana Bancila

Los Angeles, California, 90048, United States

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endobariatric procedure

Procedure

Endoscopic sleeve gastroplasty or transoral outlet reduction

Primary outcomes

  1. 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

    The investigators will compare mean percentage total body weight loss to baseline, at 1 month, 3 months, 6 months and 1 year post procedure.

Secondary outcomes

  1. Changes in hormonal profiles after various endoscopic bariatric therapies

    Time frame: Baseline/pre-procedure, 3 months, 6 months

    Repeated blood draws will be performed, and the following hormones will be measured: ghrelin, glucagon-like peptide 1 (GLP-1), peptide YY (PYY), gastric inhibitory polypeptide (GIP), and oxyntomodulin. We will compare changes over time in hormonal levels after EBT to baseline, 3 months, and 6 months post-procedure.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2022
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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