Gastrointestinal Diseases, Gastroparesis, Stomach Diseases
Conditions
Keywords
gastroparesis, Digestive, Gastrointestinal, Stomach, Motility, Non-Invasive, Capsule, GI, Device, Digestive System Diseases
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
The SmartPill Corporation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria For Healthy Subjects: 1. Healthy males and females between ages 18-65 years of age with no gastrointestinal disease as screened by the GI Disease Screening Questionnaire 2. Average bowel movement frequency of at least one bowel movement within 48 hours 3. Subjects with high probability for compliance and completion of the study Inclusion Criteria For Subjects with Gastroparesis: 1. Abnormal gastric emptying as defined by local standards and documented by nuclear medicine scintigraphy performed within the last two years. 2. Males and females between ages 18-65 years of age. 3. Average bowel movement frequency of at least one bowel movement within 72 hours 4. Subjects with high probability for compliance and completion of the study 5. Upper endoscopy or upper GI within last 3 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | Continuous time measure until capsule elimination |
| To characterize total GI transit time in healthy subjects | Continuous tume measure until capsule elimination |
Countries
United States
Outcome results
None listed