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

Completed

• Conditions: Gastrointestinal Diseases; Stomach Diseases; Gastroparesis

• Registration Number: NCT00128284
• Lead Sponsor: The SmartPill Corporation

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-09
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-21
• Last Update Posted: 2008-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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.

Exclusion Criteria

Exclusion Criteria For Healthy Subjects:

1. Prior GI surgery
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.

Exclusion Criteria For Subjects with Gastroparesis:

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Division of Gastroenterology and Hepatology at KUMC; 🇺🇸 Kansas City, Kansas, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Temple University Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Louisville Medical Center; 🇺🇸 Louisville, Kentucky, United States

VA Medical Center; 🇺🇸 Buffalo, New York, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States