ClinicalTrials.gg
Status unknownNCT05514288Updated Aug 26, 2024

Benefits of Endoscopic Bariatric Procedures

An interventional study of Endobariatric procedure in Obesity, sponsored by Cedars-Sinai Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Obesity

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03

In context

Obesity

6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 20 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 455 studies on the registry; 108 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Endoscopic sleeve gastroplasty/Transoral outlet reduction

    Procedure: Endobariatric procedure

Interventions

  • ProcedureEndobariatric procedure

    Endoscopic sleeve gastroplasty or transoral outlet reduction

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure

Secondary outcomes

  1. 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.

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

07

Study locations

1 of 1 sites recruiting
  • Liliana Bancila
    Los Angeles, California 90048, United States
    • Liliana Bancila · Contact
    • Kenneth H Park, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05514288
Responsible party
Kenneth Park (MD, Assistant Professor of Medicine Cedars-Sinai Medical Center, Cedars-Sinai Medical Center) — Principal investigator
First posted
Aug 24, 2022
Start date
Nov 1, 2022
Primary completion
Sep 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Aug 26, 2024

Study contacts

Liliana Bancila, PhD
Contact
Liliana.Bancila@cshs.org
310-423-3872
Joseph Meza
Contact
Joseph.Meza@cshs.org
310-423-6082
Kenneth Park, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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