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
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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 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 |

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

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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 |
Inclusion Criteria:
- Males and females between ages of 18-80 years of age with symptoms of gastroparesis for at least 12 weeks.
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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

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
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 |
Principal Investigator: | Braden Kuo, Dr. |
Documents provided by Medtronic - MITG:
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 |
Gastroparesis SmartPill Monitoring System (SPM) Gastric Emptying Scintigraphy (GES) |
Gastroparesis Stomach Diseases Gastrointestinal Diseases |
Digestive System Diseases Paralysis Neurologic Manifestations |