Clinical Trial: A Comparison of SmartPill Capsule with Scintigraphy for Determining Gastric Residence Time

This study is currently recruiting patients.
Verified by SmartPill Diagnostics August 2005

Sponsored by: SmartPill Diagnostics
Information provided by: SmartPill Diagnostics
ClinicalTrials.gov Identifier: NCT00128284

Purpose

The purpose of this study is to determine the correlation between the SmartPill diagnostic capsule and gastric scintigraphy to determining Gastric Residence Time.
Condition Intervention
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastroparesis
 Device: SmartPill Diagnostics, Inc. ACT GI Monitoring System

MedlinePlus related topics:  Digestive Diseases;   Paralysis;   Stomach Disorders

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-equivalence Study

Official Title: A Comparison Trial of SmartPill Diagnostics, Inc. ACT GI Monitoring System with Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time

Further Study Details: 
Primary Outcomes: 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.
Secondary Outcomes: · To demonstrate that the gastric residence time as determined by SmartPill GI Monitoring System can discriminate between healthy human subjects and patients with gastroparesis.; · To characterize pressure patterns within the antrum and duodenum in healthy subjects and patients with documented gastroparesis.; · To characterize total GI transit time in healthy subjects
Expected Total Enrollment:  130

Study start: February 2005;  Expected completion: October 2005
Last follow-up: October 2005;  Data entry closure: October 2005

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.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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 (See Appendix II)
  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. 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 laproscopic 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)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00128284

Mary Eileen McPhee, RN, MS      716/633-3463  Ext. 250    mary@cognigencorp.com
Jack Semler, PhD      716/882-0701  Ext. 101    jrsemler@smartpillcorp.com

Kansas
      Division of Gastroenterology and Hepatology at KUMC, Kansas City,  Kansas,  66160,  United States; Recruiting
Irene Sarosiec  913-588-3852    isarosie@kumc.edu 
Richard McCallum, MD,  Principal Investigator

Kentucky
      University of Louisville Hospital, Louisville,  Kentucky,  40202,  United States; Recruiting
Lorie Matthews  502-852-6105    Lorie.matthews@lousiville.edu 
John Wo, MD,  Principal Investigator

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Annabel Yuen  617-726-0196    anyuen@partners.org 
Braden Kuo, MD,  Principal Investigator

New York
      University of Buffalo SUNY, Buffalo,  New York,  14215,  United States; Recruiting
Greg Gudleski  716-898-6254 
Michael Sitrin, MD,  Principal Investigator

North Carolina
      Wake Forrest University School of Medicine, Winston Salem,  North Carolina,  27157,  United States; Recruiting
Judy Hooker  336-713-7301    jhooker@wfubmc.edu 
Kenneth Koch,  Principal Investigator

Pennsylvania
      Temple University, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
Amiya Palit, MD  215-707-5477    Amiya.palit@temple.edu 
Henry Parkman, MD,  Principal Investigator

Study chairs or principal investigators

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

More Information

Study ID Numbers:  102204
Last Updated:  August 8, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128284
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23

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