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| ID | Type | Description | Link |
|---|---|---|---|
| NYSTAR C020118 | |||
| NIH DK069614 |
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The purpose of this study is to determine the correlation between gastric residence time of the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled meal as measured by gastric emptying scintigraphy.
Gastric emptying scintigraphy is considered the gold standard for evaluating gastric emptying and is widely available. Accurate characterization of gastric emptying may guide medical and surgical treatment choices. In addition, these techniques may allow for monitoring of therapeutic results for follow-up patient management.
The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | healthy adult subjects with no history or current gastrointestinal disorders or conditions | ||
| Gastroparesis | Subjects with documented gastroparesis |
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| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the correlation between the gastric residence time as determined by SmartPill GI Monitoring System and the gastric emptying time of a radiolabeled meal in both healthy subjects and patients with documented gastroparesis. | 30 minute intervals up to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that the gastric residence time as determined by SmartPill GI Monitoring System can discriminate between healthy human subjects and patients with gastroparesis | Continuous time measure until capsule elimination | |
| To characterize pressure patterns within the antrum and duodenum in healthy subjects and patients with documented gastroparesis |
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Inclusion Criteria:
Inclusion Criteria For Healthy Subjects:
Inclusion Criteria For Subjects with Gastroparesis:
Exclusion Criteria:
Exclusion Criteria For Healthy Subjects:
Exclusion Criteria For Subjects with Gastroparesis:
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patients with gastroparesis referred to a tertiary motility center
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| Name | Affiliation | Role |
|---|---|---|
| Jack Semler, PhD | SmartPill Corporation | Study Director |
| Braden Kuo, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology and Hepatology at KUMC | Kansas City | Kansas | 66160 | United States | ||
| University of Louisville Medical Center |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D018589 | Gastroparesis |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Continuous time measure until capsule elimination |
| To characterize total GI transit time in healthy subjects | Continuous tume measure until capsule elimination |
| Louisville |
| Kentucky |
| 40292 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| VA Medical Center | Buffalo | New York | 14215 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Temple University Medical Center | Philadelphia | Pennsylvania | 19140 | United States |