Direct Comparison of Short- And Long-Term Gastric Emptying By Nuclear Scintigraphy and Gastric Emptying Breath Test in Subjects Undergoing Endoscopic Gastric Remodeling For Weight Loss

Mayo Clinic1 site in 1 country5 target enrollmentJuly 16, 2020

ConditionsWeight Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Weight Loss
Sponsor: Mayo Clinic
Enrollment: 5
Locations: 1
Primary Endpoint: Change of T1/2
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare a less invasive breath test against the current standard for assessing gastric (stomach) emptying. The current standard of care is a procedure called Nuclear Scintigraphy of a Solid Meal (NSSM). This study will compare this method to a Gastric Emptying Breath Test (GEBT).

Registry

clinicaltrials.gov

Start Date

July 16, 2020

End Date

November 23, 2020

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Barham K. Abu Dayyeh, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•Subjects must be 22-65 years of age at time of enrollment
•Subjects must already be consented to 17-007934 or 19-001254
•Subject must be agreeable and compliant with study requirements, including up to 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 a form of birth control or abstinence 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

•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

Outcomes

Primary Outcomes

Change of T1/2

Time Frame: Baseline, 2 months, 6 months

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 EGRWL procedure.