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

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