Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic - MITG Identifier:
First received: December 15, 2013
Last updated: September 19, 2015
Last verified: September 2015

This protocol is designed to validate use of the SPM for diagnosis of delayed gastric emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study on patient management in the gastroparetic populations. Patients with symptoms of gastroparesis will be recruited.

Patients will undergo concurrent gastric scintigraphy and SPM testing to determine the presence or absence of delayed gastric emptying based on predetermined diagnostic cutoffs for each technique.

Condition Intervention
Device: SmartPill Monitoring System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Management With SmartPill Motility Monitoring System and Validation of the SmartPill Five Hour Cutoff in Patients With Symptoms of Gastroparesis

Resource links provided by NLM:

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • Per patient device agreement between SmartPill Motility Monitoring System gastric emptying time & gastric Emptying scintigraphy test in patients with symptoms of gastroparesis [ Time Frame: an expected average of two weeks from study procedure ] [ Designated as safety issue: No ]
    Per patient device agreement for the diagnosis of delayed gastric emptying between SmartPill Motility Monitoring System (SPM) gastric emptying time (GET >5 hours) and the non-reference standard, gastric Emptying scintigraphy test (>10% retention of a solid meal at 4 hours) in patients with symptoms of gastroparesis

Secondary Outcome Measures:
  • Agreement between Gastric emptying time of SmartPill capsule and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy [ Time Frame: an expected average of two weeks from study procedure ] [ Designated as safety issue: No ]
    Agreement between Gastric emptying time of SmartPill capsule (GET>8hrs= severe) and gastroduodenal contractility (36) and percent of radiolabeled meal retained at 4 hours on scintigraphy (>35% = severe)

Enrollment: 172
Study Start Date: January 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SmartPill Monitoring System
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Device: SmartPill Monitoring System
Other Name: SPM


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females between ages of 18-80 years of age with symptoms of gastroparesis for at least 12 weeks.
  • Presenting with 2 or more of the following symptoms or signs which, in the opinion of the site investigator, are suggestive of a diagnosis of gastroparesis:

    • 1 Nausea, vomiting, or retching (dry heaves)
    • 2 Postprandial fullness or early satiety
    • 3 Bloating or visible abdominal distention
    • 4 Postprandial discomfort or pain
  • Ability to stop proton pump inhibitors for 7 days and histamine2 receptor antagonists, prokinetic agents, narcotic agents, anticholinergic drugs, and cannabinoids 3 days prior to SPM and gastric scintigraphy testing.
  • No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes [hemoglobin A1c >10% within the past 6 months], electrolyte imbalance).
  • An upper endoscopy or upper gastrointestinal barium series within the past 2 years showing no organic disease that is potentially causative of symptoms.
  • High probability of compliance and completion of study.

Exclusion Criteria:

  • Participation in previous SmartPill clinical trials.
  • Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
  • Dysphagia to solid food or pills.
  • Prior surgery involving the luminal gastrointestinal tract (cholecystectomy, appendectomy, and hysterectomy are permitted if performed > 3 months prior to SPM test).
  • Any abdominal or pelvic surgery within the past 3 months
  • Known or history of inflammatory bowel disease.
  • History of diverticulitis, diverticular stricture, and other intestinal strictures.
  • Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)
  • Tobacco or alcohol use within eight hours prior to capsule ingestion.
  • BMI > 40 kg/m2.
  • Allergies to eggs, bread, or jam.
  • Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (Urine pregnancy testing will be performed on female subjects of child-bearing potential prior to capsule ingestion and gastric scintigraphy).
  • Use of cardiac medical devices such as pacemakers and defibrillators (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion devices, insulin pumps, continuous glucose monitors are permitted).
  • Uncontrolled diabetes with a hemoglobin A1c >10%.
  • Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule
  Contacts and Locations
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Please refer to this study by its identifier: NCT02022826

United States, California
Stanford University
Palo Alto, California, United States, 94305
United States, Florida
Florida Digestive Health
Largo, Florida, United States, 33777
Miami miller school of Medicin
Miami, Florida, United States
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30909
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
United States, Texas
Texas Tech University
El Paso, Texas, United States, 79905
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Medtronic - MITG
Principal Investigator: Braden Kuo, Dr.
  More Information

No publications provided

Responsible Party: Medtronic - MITG Identifier: NCT02022826     History of Changes
Other Study ID Numbers: MA-501
Study First Received: December 15, 2013
Last Updated: September 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic - MITG:
SmartPill Monitoring System (SPM)
Gastric Emptying Scintigraphy (GES)

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Neurologic Manifestations
Signs and Symptoms
Stomach Diseases processed this record on October 08, 2015