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