Status:
TERMINATED
Gastric Emptying Using Two Imaging Methods for Those Who Have Undergone POSE2 Weight Loss Procedure
Lead Sponsor:
Mayo Clinic
Conditions:
Weight Loss
Eligibility:
All Genders
22-65 years
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 Sc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 23 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04502732
Start Date
July 16 2020
End Date
November 23 2020
Last Update
November 2 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905