A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time

Completed

Conditions studied: Gastrointestinal Diseases, Stomach Diseases, Gastroparesis

In brief

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.

Key facts

Study ID

NCT00128284

Run by

The SmartPill Corporation

People needed

148

Starts

2005-02-01

Expected to finish

2005-10-01

Last updated by the study team

2008-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.