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

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ClinicalTrials.gov Identifier: NCT02022826

Recruitment Status : Terminated (sponsor internal decision)

First Posted : December 30, 2013

Results First Posted : November 30, 2017

Last Update Posted : November 30, 2017

Sponsor:

Information provided by (Responsible Party):

Medtronic - MITG

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Gastroparesis	Device: SmartPill Monitoring System	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	167 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
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
Study Start Date :	January 2014
Actual Primary Completion Date :	March 2017
Actual Study Completion Date :	March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Genetic and Rare Diseases Information Center resources: Gastroparesis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: SmartPill Monitoring System patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test	Device: SmartPill Monitoring System Other Name: SPM

Outcome Measures

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 ]
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 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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022826

Locations

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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
Clinsearch,LLC
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

Investigators

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Principal Investigator:	Braden Kuo, Dr.

Study Documents (Full-Text)

Documents provided by Medtronic - MITG:

Study Protocol [PDF] March 15, 2015

Statistical Analysis Plan [PDF] January 5, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee AA, Rao K, Parkman HP, McCallum RW, Sarosiek I, Nguyen LA, Wo JM, Schulman MI, Moshiree B, Rao S, Kuo B, Hasler WL. Baseline Predictors of Longitudinal Changes in Symptom Severity and Quality of Life in Patients With Suspected Gastroparesis. Clin Gastroenterol Hepatol. 2020 Sep 21. pii: S1542-3565(20)31293-3. doi: 10.1016/j.cgh.2020.09.032. [Epub ahead of print]

Hasler WL, Rao SSC, McCallum RW, Krause RA, Nguyen LA, Schulman MI, Lee AA, Moshiree B, Wo JM, Parkman HP, Sarosiek I, Wilding GE, Kuo B. Influence of Gastric Emptying and Gut Transit Testing on Clinical Management Decisions in Suspected Gastroparesis. Clin Transl Gastroenterol. 2019 Oct;10(10):e00084. doi: 10.14309/ctg.0000000000000084.

Lee AA, Rao S, Nguyen LA, Moshiree B, Sarosiek I, Schulman MI, Wo JM, Parkman HP, Wilding GE, McCallum RW, Hasler WL, Kuo B. Validation of Diagnostic and Performance Characteristics of the Wireless Motility Capsule in Patients With Suspected Gastroparesis. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1770-1779.e2. doi: 10.1016/j.cgh.2018.11.063. Epub 2018 Dec 14.

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Responsible Party:	Medtronic - MITG
ClinicalTrials.gov Identifier:	NCT02022826
Other Study ID Numbers:	MA-501
First Posted:	December 30, 2013 Key Record Dates
Results First Posted:	November 30, 2017
Last Update Posted:	November 30, 2017
Last Verified:	August 2017

Keywords provided by Medtronic - MITG:


Gastroparesis SmartPill Monitoring System (SPM) Gastric Emptying Scintigraphy (GES)

Additional relevant MeSH terms:

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Gastroparesis Stomach Diseases Gastrointestinal Diseases	Digestive System Diseases Paralysis Neurologic Manifestations

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