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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Given Imaging Ltd.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT02022826
First received: December 15, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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
Gastroparesis
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 Given Imaging Ltd.:

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)


Estimated Enrollment: 250
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022826

Contacts
Contact: Braden Kuo, Dr. bkuo@partners.org

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Principal Investigator: Linda Nguyen, Dr.         
United States, Florida
Florida Digestive Health Recruiting
Largo, Florida, United States, 33777
Principal Investigator: Michael Schulman, Dr.         
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30909
Principal Investigator: Satish S.C. Rao, Prof.         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: John Wo, Dr.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Braden Kuo, Dr.         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: William Hasler, Dr.         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Principal Investigator: Henry Parkman, Dr.         
United States, Tennessee
Clinsearch,LLC Recruiting
Chattanooga, Tennessee, United States, 37421
Principal Investigator: Richard Krause, Dr.         
United States, Texas
Texas Tech University Recruiting
El Paso, Texas, United States, 79905
Principal Investigator: Richard McCallum, Prof.         
United States, Vermont
Fletcher Allen Health Care Recruiting
Burlington, Vermont, United States, 05401
Principal Investigator: Allen Lee, Dr.         
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Braden Kuo, Dr.
  More Information

No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT02022826     History of Changes
Other Study ID Numbers: MA-501
Study First Received: December 15, 2013
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Given Imaging Ltd.:
Gastroparesis
SmartPill Monitoring System (SPM)
Gastric Emptying Scintigraphy (GES)

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014