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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastroparesis

Intervention / Treatment
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* Device: SmartPill Monitoring System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmartPill Monitoring System<br>patients with symptoms of Gastroparesis will undergo the SmartPill monitoring system test | Device: SmartPill Monitoring System<br> <br> * Other names: SPM;|

What is the study measuring?
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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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroparesis, SmartPill Monitoring System (SPM), Gastric Emptying Scintigraphy (GES)