RECRUITING

Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Conditions

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 will be a prospective, registry study of an investigational procedure for at least 12 standard of care visits up to 1 year after subject consents for study. Subjects will be enrolled between 8/1/2018 and 8/1/2023. Subjects will undergo a clinically indicated endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care. Disclaimer: To undergo the procedure there is an out of pocket expense for $9000.

Official Title

Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty

Quick Facts

Study Start:2018-08-27
Study Completion:2024-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04640688

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Able to comprehend and provided written informed consent
  3. * Willing to comply with the substantial lifelong dietary restrictions required by the procedure
  4. * History of failure with non-surgical weight-loss methods
  5. * Willing to follow protocol requirements, including providing informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
  6. * Women of childbearing potential ( not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
  1. * Below 18 years of age
  2. * Prohibitive anesthetic risk

Contacts and Locations

Study Contact

Crystee Cooper, DHEd
CONTACT
214-947-1280
clinicalresearch@mhd.com
Zaid Haddadin, MS
CONTACT
214-947-1280
clinicalresearch@mhd.com

Principal Investigator

Prashant Kedia, MD
PRINCIPAL_INVESTIGATOR
Methodist Dallas Medical Center

Study Locations (Sites)

Methodist Dallas Medical Center
Dallas, Texas, 75023
United States

Collaborators and Investigators

Sponsor: Methodist Health System

  • Prashant Kedia, MD, PRINCIPAL_INVESTIGATOR, Methodist Dallas 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 Date2018-08-27
Study Completion Date2024-08-01

Study Record Updates

Study Start Date2018-08-27
Study Completion Date2024-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity