sponsor internal decision

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.

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