Status:
COMPLETED
A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time
Lead Sponsor:
The SmartPill Corporation
Conditions:
Gastrointestinal Diseases
Stomach Diseases
Eligibility:
All Genders
18-65 years
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...
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 trea...
Eligibility Criteria
Inclusion
- Inclusion Criteria For Healthy Subjects:
- Healthy males and females between ages 18-65 years of age with no gastrointestinal disease as screened by the GI Disease Screening Questionnaire
- Average bowel movement frequency of at least one bowel movement within 48 hours
- Subjects with high probability for compliance and completion of the study
- Inclusion Criteria For Subjects with Gastroparesis:
- Abnormal gastric emptying as defined by local standards and documented by nuclear medicine scintigraphy performed within the last two years.
- Males and females between ages 18-65 years of age.
- Average bowel movement frequency of at least one bowel movement within 72 hours
- Subjects with high probability for compliance and completion of the study
- Upper endoscopy or upper GI within last 3 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.
Exclusion
- Exclusion Criteria For Healthy Subjects:
- Prior GI surgery
- Surgery within the past 3 months
- Diverticulitis
- Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
- Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
- Body mass index (BMI) \> 35
- Allergies to components of the test meal including eggs, bread, and jam.
- Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
- Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
- Exclusion Criteria For Subjects with Gastroparesis:
- History of gastric bezoar
- Severe dysphagia to solid food and pills
- Severe vomiting more than 1 time per day
- Diverticulitis
- Severe daily abdominal pain requiring medications for relief
- Severe weight loss, greater than 10 lbs over the preceding 2 months.
- Uncontrolled diabetes with a hemoglobin A1C greater than 10.
- Excessively delayed gastric emptying time: more than 90% of a standard egg meal retained after 2 hours.
- Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery.
- Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy
- Surgery within the past 3 months
- Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
- Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
- BMI \> 35
- Allergies to components of the test meal including eggs, bread, and jam
- Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
Key Trial Info
Start Date :
February 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00128284
Start Date
February 1 2005
End Date
October 1 2005
Last Update
May 22 2008
Active Locations (7)
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1
Division of Gastroenterology and Hepatology at KUMC
Kansas City, Kansas, United States, 66160
2
University of Louisville Medical Center
Louisville, Kentucky, United States, 40292
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109