Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility

Inclusion Criteria

Must meet one of the following categories:

• Gastroparesis

Meets diagnostic criteria for gastroparesis:

• Evidence of delayed gastric emptying documented with a standard 2 hour or 4 hour gastric emptying scintigraphy exam
• Absence of mechanical obstruction
• Exhibits cardinal symptoms of early satiety, post-prandial fullness, nausea, vomiting, bloating, and upper abdominal pain

Gastrointestinal cardinal symptom index (GCSI) score > 0 (i.e., the presence of at least mild severity of >1 of 3 symptoms of nausea/vomiting, postprandial fullness/early satiety, and/or bloating).

• Functional Dyspepsia

Meets Rome IV diagnostic criteria for functional dyspepsia:

• Criteria fulfilled for the last 3 months with symptom onset at least six months prior to diagnosis
• No evidence of organic, systemic, or metabolic disease that is likely to explain the symptoms on routine investigations (including at upper endoscopy)
• Meet criteria for Epigastric pain syndrome and/or Postprandial distress syndrome

Epigastric Pain Syndrome At least 1 of the following symptoms at least 1 day per week

• Bothersome epigastric pain
• Bothersome epigastric burning

Postprandial Distress Syndrome At least 1 of the following symptoms at least 3 days per week

• Bothersome postprandial fullness
• Bothersome early satiation
• G-POEM
• The G-POEM procedure must have been performed at least 4 weeks prior to screening.
• GCSI score is 9 or metabolic crisis in past 60 days).
• Use of prohibited medication or medication with anti-nausea, antiemetic, neuromodulating, or prokinetic effect within 2 weeks of the screening visit EXCEPT when administered on a stable daily dosing schedule (stable for at least 1 month prior to the screening visit).
• Use of as needed or daily opioids within the past 1 month.
• Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 3 months of the Screening visit.
• Altered mental status (e.g., hepatic encephalopathy) that limits the ability to swallow a capsule
• Expected to have Magnetic Resonance Imaging (MRI) examination within 30 days.
• No reliable contact information - no phone, no permanent address.
• Pacemaker or ICD
• Inability to avoid using the bathroom for urination and/or bowel movements for the duration of the study.
• Metal Implant (ie metal hip arthroplasty, surgical mesh, coronary or arterial stent)
• Prior bowel surgery
• Severe claustrophobia
• Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.