Benefits of Endoscopic Bariatric Procedures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Procedure: Endobariatric procedure

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liliana Bancila, PhD; Phone Number: 310-423-3872; Email: Liliana.Bancila@cshs.org
• Study Contact Backup: Name: Joseph Meza; Phone Number: 310-423-6082; Email: Joseph.Meza@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Liliana Bancila
      • Contact: Liliana Bancila
      • Principal Investigator: Kenneth H Park, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Endoscopic sleeve gastroplasty/Transoral outlet reduction	Procedure: Endobariatric procedure; Endoscopic sleeve gastroplasty or transoral outlet reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight after various endoscopic bariatric therapies	The investigators will compare mean percentage total body weight loss to baseline, at 1 month, 3 months, 6 months and 1 year post procedure.	Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in hormonal profiles after various endoscopic bariatric therapies	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.	Baseline/pre-procedure, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Kenneth Park, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00002145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No