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

NCT04502732 | Terminated

• 1 other identifier: 20-002882
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational

NSSM and GEBT

Other: NSSM and GEBT

Interventions

NSSM and GEBT OTHER

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.

Observational

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those eligible from relevant sub-studies.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barham Abu Dayyeh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: July 16, 2020
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)