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

• ClinicalTrials.gov Identifier: NCT00128284
• Recruitment Status: Completed
• First Posted: August 9, 2005
• Last Update Posted: May 22, 2008
• Sponsor: The SmartPill Corporation
• Information provided by: The SmartPill Corporation

Study Description

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.

Condition or disease
Gastrointestinal Diseases; Stomach Diseases; Gastroparesis

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 Design

• Study Type: Observational
• Actual Enrollment: 148 participants
• Observational Model: Case Control
• Time Perspective: Prospective
• Official Title: A Comparison Trial of SmartPill Corporation GI Monitoring System With Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time
• Study Start Date: February 2005
• Actual Primary Completion Date: October 2005
• Actual Study Completion Date: October 2005

Groups and Cohorts

Group/Cohort
Normal; healthy adult subjects with no history or current gastrointestinal disorders or conditions
Gastroparesis; Subjects with documented gastroparesis

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 30 minute intervals up to 6 hours ]

Secondary Outcome Measures :

1. To demonstrate that the gastric residence time as determined by SmartPill GI Monitoring System can discriminate between healthy human subjects and patients with gastroparesis [ Time Frame: Continuous time measure until capsule elimination ]
2. To characterize pressure patterns within the antrum and duodenum in healthy subjects and patients with documented gastroparesis [ Time Frame: Continuous time measure until capsule elimination ]
3. To characterize total GI transit time in healthy subjects [ Time Frame: Continuous tume measure until capsule elimination ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

patients with gastroparesis referred to a tertiary motility center

Criteria

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)

Contacts and Locations

Locations

United States, Kansas

Division of Gastroenterology and Hepatology at KUMC

Kansas City, Kansas, United States, 66160

United States, Kentucky

University of Louisville Medical Center

Louisville, Kentucky, United States, 40292

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Michigan

University of Michigan Medical Center

Ann Arbor, Michigan, United States, 48109

United States, New York

VA Medical Center

Buffalo, New York, United States, 14215

United States, North Carolina

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

United States, Pennsylvania

Temple University Medical Center

Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

The SmartPill Corporation

Investigators

• Study Director: Jack Semler, PhD; SmartPill Corporation
• Principal Investigator: Braden Kuo, MD; Massachusetts General Hospital

More Information

• Responsible Party: John R. Semler/Chief Technology Officer, The SmartPill Corporation
• ClinicalTrials.gov Identifier: NCT00128284
• Other Study ID Numbers: 102204; NYSTAR C020118; NIH DK069614
• First Posted: August 9, 2005
• Last Update Posted: May 22, 2008
• Last Verified: May 2008

Keywords provided by The SmartPill Corporation:

gastroparesis; Digestive; Gastrointestinal; Stomach; Motility; Non-Invasive; Capsule; GI; Device; Digestive System Diseases

Additional relevant MeSH terms:

Gastroparesis; Gastrointestinal Diseases; Stomach Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms