Gastric Emptying Using Two Imaging Methods for Those Who Have Undergone POSE2 Weight Loss Procedure
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 20-002882
NCT ID: NCT04502732
About this study
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).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
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