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

November 1, 2017 updated by: Medtronic - MITG

Clinical Management With SmartPill Motility Monitoring System and Validation of the SmartPill Five Hour Cutoff in Patients With Symptoms of Gastroparesis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University
    • Florida
      • Largo, Florida, United States, 33777
        • Florida Digestive Health
      • Miami, Florida, United States
        • Miami miller school of Medicin
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Georgia Regents University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Clinsearch,LLC
    • Texas
      • El Paso, Texas, United States, 79905
        • Texas Tech University
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SmartPill Monitoring System
patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test
Device: SmartPill Monitoring System
Other Names:
  • SPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
an expected average of two weeks from study procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement Between Gastric Emptying Time of SmartPill Capsule and Gastroduodenal Contractility and Percent of Radiolabeled Meal Retained at 4 Hours on Scintigraphy for Severe Gastroparesis
Time Frame: an expected average of two weeks from study procedure
Agreement between Gastric emptying time of SmartPill capsule (GET>8hrs= severe) and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy (>35% = severe)
an expected average of two weeks from study procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

  • Principal Investigator: Braden Kuo, Dr.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

December 15, 2013

First Submitted That Met QC Criteria

December 22, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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