A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time
NCT ID: NCT00128284
Last Updated: 2008-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
148 participants
OBSERVATIONAL
2005-02-28
2005-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normal
healthy adult subjects with no history or current gastrointestinal disorders or conditions
No interventions assigned to this group
Gastroparesis
Subjects with documented gastroparesis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
Exclusion Criteria
2. Surgery within the past 3 months
3. Diverticulitis
4. Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
5. Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
6. Body mass index (BMI) \> 35
7. Allergies to components of the test meal including eggs, bread, and jam.
8. Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
9. Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
1. History of gastric bezoar
2. Severe dysphagia to solid food and pills
3. Severe vomiting more than 1 time per day
4. Diverticulitis
5. Severe daily abdominal pain requiring medications for relief
6. Severe weight loss, greater than 10 lbs over the preceding 2 months.
7. Uncontrolled diabetes with a hemoglobin A1C greater than 10.
8. Excessively delayed gastric emptying time: more than 90% of a standard egg meal retained after 2 hours.
9. Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery.
10. Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy
11. Surgery within the past 3 months
12. Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
13. Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
14. BMI \> 35
15. Allergies to components of the test meal including eggs, bread, and jam
16. Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
18 Years
65 Years
ALL
Yes
Sponsors
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The SmartPill Corporation
INDUSTRY
Responsible Party
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The SmartPill Corporation
Principal Investigators
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Jack Semler, PhD
Role: STUDY_DIRECTOR
SmartPill Corporation
Braden Kuo, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Division of Gastroenterology and Hepatology at KUMC
Kansas City, Kansas, United States
University of Louisville Medical Center
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
VA Medical Center
Buffalo, New York, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Temple University Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NYSTAR C020118
Identifier Type: -
Identifier Source: secondary_id
NIH DK069614
Identifier Type: -
Identifier Source: secondary_id
102204
Identifier Type: -
Identifier Source: org_study_id