This protocol is designed to validate use of the SPM for diagnosis of delayed gastric emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study on patient management in the gastroparetic populations. Patients with symptoms of gastroparesis will be recruited. Patients will undergo concurrent gastric scintigraphy and SPM testing to determine the presence or absence of delayed gastric emptying based on predetermined diagnostic cutoffs for each technique.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
167
Stanford University
Palo Alto, California, United States
Florida Digestive Health
Largo, Florida, United States
Miami miller school of Medicin
Miami, Florida, United States
Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis
Per patient device agreement for the diagnosis of delayed gastric emptying between SmartPill Motility Monitoring System (SPM) gastric emptying time (GET \>5 hours) and the non-reference standard, gastric Emptying scintigraphy test (\>10% retention of a solid meal at 4 hours) in patients with symptoms of gastroparesis
Time frame: an expected average of two weeks from study procedure
Agreement Between Gastric Emptying Time of SmartPill Capsule and Gastroduodenal Contractility and Percent of Radiolabeled Meal Retained at 4 Hours on Scintigraphy for Severe Gastroparesis
Agreement between Gastric emptying time of SmartPill capsule (GET\>8hrs= severe) and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy (\>35% = severe)
Time frame: an expected average of two weeks from study procedure
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Georgia Regents University
Augusta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Temple University
Philadelphia, Pennsylvania, United States
Clinsearch,LLC
Chattanooga, Tennessee, United States
Texas Tech University
El Paso, Texas, United States
...and 1 more locations