RECRUITING

Benefits of Endoscopic Bariatric Procedures

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Conditions

Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-11-01
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05514288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients who are considering undergoing EBT for weight loss
  2. * Patients with a BMI \>30 kg/m2 (without obesity related comorbidities)
  3. * Patients with a BMI \>27 kg/m2 (with obesity related comorbidities)
  4. * Patients willing and able to comply with study requirements for follow-up
  5. * Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight
  6. * Individuals 18 years old or older are included
  1. * Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
  2. * Esophageal, gastric or duodenal malignancy
  3. * Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
  4. * 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
  5. * Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
  6. * General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the investigator
  7. * Pregnant or planning to become pregnant during period of study participation
  8. * Patient refuses or is unable to provide written informed consent
  9. * Prior surgical or endoscopic anti-reflux procedure
  10. * Patients who are unwilling or unable to comply with the follow-up study schedule

Contacts and Locations

Study Contact

Liliana Bancila, PhD
CONTACT
310-423-3872
Liliana.Bancila@cshs.org
Joseph Meza
CONTACT
310-423-6082
Joseph.Meza@cshs.org

Principal Investigator

Kenneth Park, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Liliana Bancila
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Kenneth Park, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2025-09

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity