A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time - Over 65 Years Old

Gastroparesis Clinical Trial

— GETOver65  

Official title:

A Comparison Trial of SmartPill Corporation GI Monitoring System With Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time - In Subjects Over 65 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682877
• Other study ID #: 102204a
• Status: Completed
• Phase: N/A
• First received: May 20, 2008
• Last updated: May 22, 2008
• Start date: July 2007
• Est. completion date: November 2007

Study information

• Verified date: May 2008
• Source: The SmartPill Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 for subjects 65 years of age and older.

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. This trial is for subjects 65 years of age and older.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria For Healthy Subjects:

• Healthy males and females between ages 65-80 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 Criteria:

• 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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Gastroparesis
• Stomach Diseases

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Division of Gastroenterology and Hepatology at KUMC	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
The SmartPill Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To characterize pressure patterns within the antrum and duodenum in healthy subjects and patients with documented gastroparesis		Continuous time measure until capsule elimination	No
Secondary	To characterize total GI transit time in healthy subjects		Continuous time measure until capsule elimination	No