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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04502732
• Other study ID #: 20-002882
• Status: Terminated
• Start date: July 16, 2020
• Est. completion date: November 23, 2020

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Other:
• NSSM and GEBT
The time to half gastric emptying (T1/2) will be assessed via Gastric Emptying Breath Tests (GEBT) and Nuclear Scintigraphy of a Solid Meal (NSSM) at baseline, 2 months, and 6 months. This data will be collected from seven adult subjects, with obesity, who have recently received Endoscopic Bariatric and Metabolic Therapy.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of T1/2	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.	Baseline, 2 months, 6 months

External Links

•   Mayo Clinic Clinical Trials