Benefits of Endoscopic Bariatric Procedures

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514288
• Other study ID #: STUDY00002145
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Cedars-Sinai Medical Center
• Contact: Liliana Bancila, PhD
• Phone: 310-423-3872
• Email: Liliana.Bancila[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Endobariatric procedure
Endoscopic sleeve gastroplasty or transoral outlet reduction

Locations

Country	Name	City	State
United States	Liliana Bancila	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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