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

NCT00682877 | Completed

• 1 other identifier: 102204a
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

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 for subjects 65 years of age and older.

Conditions

Gastrointestinal Diseases; Stomach Diseases; Gastroparesis

Keywords

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

Outcome Measures

Primary Outcomes (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.

  30 minute intervals up to 6 hours

Secondary Outcomes (3)

• 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 time measure until capsule elimination

Study Arms (2)

Normal

healthy adult subjects with no history or current gastrointestinal disorders or conditions

Gastroparesis

Subjects with documented gastroparesis

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with gastroparesis referred to a tertiary motility center - 65 years of age and older.

You may qualify if:

• 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
• 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:

• 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.
• 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.

Sponsors & Collaborators

• The SmartPill Corporation: lead

Study Sites (2)

Division of Gastroenterology and Hepatology at KUMC

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Stomach Diseases; Gastroparesis; Digestive System Diseases

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Braden Kuo, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• John R Semler, PhD

  SmartPill Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 23, 2008
• Study Start: July 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 23, 2008

Record last verified: 2008-05

Locations

US (2)