NCT05514288

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

August 18, 2022

Last Update Submit

August 23, 2024

Conditions

Obesity

Outcome Measures

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.

    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

    Baseline/pre-procedure, 3 months, 6 months

Study Arms (1)

Endoscopic sleeve gastroplasty/Transoral outlet reduction

OTHER
Procedure: Endobariatric procedure

Interventions

Endobariatric procedurePROCEDURE

Endoscopic sleeve gastroplasty or transoral outlet reduction

Endoscopic sleeve gastroplasty/Transoral outlet reduction

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liliana Bancila

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kenneth Park, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liliana Bancila, PhD

CONTACT

310-423-3872Liliana.Bancila@cshs.org

Joseph Meza

CONTACT

310-423-6082Joseph.Meza@cshs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor of Medicine Cedars-Sinai Medical Center

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 24, 2022

Study Start

November 1, 2022

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)