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

Terminated

• Conditions: Weight Loss
• Interventions: Other: NSSM and GEBT

• Registration Number: NCT04502732
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-16
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Primary Completion: 2020-11-23
• Study Completion: 2020-11-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	NSSM and GEBT	NSSM and GEBT

Primary Outcome Measures

Name	Time	Method
Change of T1/2	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States