Gastric Emptying Using Two Imaging Methods for Those Who Have Undergone POSE2 Weight Loss Procedure

Overview

Información sobre este estudio

The aim of this study is to compare baseline, early post-procedural (2 month), and delayed post-procedural (6 month) T1/2, as assessed by both GEBT and NSSM, in seven adult subjects with obesity who have underwent an Endoscopic Gastric Remodeling Weight Loss procedure (EGRWL).  

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • All races, ethnicities and genders are eligible for enrollment in this study. 
  • Subjects must be aged 22-65 years old. 

Additional inclusion criteria are: 

  • Provision of signed and dated informed consent.
  • Subject must be agreeable and compliant with study requirements, including the three (baseline, 2 month, and 6 month) visits, as well as undergoing GEBT and NSSM testing.
  • If female, must be post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.
  • Must be willing and able to travel, as needed, to the Investigator’s office to complete all routine follow-up visits.

Exclusion Criteria: 

Patients presenting any of the following conditions, or meeting any of the criteria below, are to be excluded from enrollment: 

  • Persons presently or soon to be incarcerated.
  • Females who are pregnant or suspect they may be pregnant.
  • Persons with nicotine and/or alcohol dependence.
  • Patients with cognitive impairment that limits their ability to make autonomous decisions. 
  • Known allergies or sensitivities to study materials (eggs and spirulina).
  • Assessed, by the physician or delegate, that enrollment would not be appropriate.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Barham Abu Dayyeh, M.D., M.P.H.

Cerrado para la inscripción

More information

Publicaciones

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CLS-20507814

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