Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility

Open to people ages 18 years and up

Must meet one of the following categories:

1. Gastroparesis

   Meets diagnostic criteria for gastroparesis:

   1. Evidence of delayed gastric emptying documented with a standard 2 hour or 4 hour gastric emptying scintigraphy exam
   2. Absence of mechanical obstruction
   3. 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).

2. Functional Dyspepsia

   Meets Rome IV diagnostic criteria for functional dyspepsia:

   1. Criteria fulfilled for the last 3 months with symptom onset at least six months prior to diagnosis
   2. No evidence of organic, systemic, or metabolic disease that is likely to explain the symptoms on routine investigations (including at upper endoscopy)
   3. 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

   1. Bothersome epigastric pain
   2. Bothersome epigastric burning

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

   1. Bothersome postprandial fullness
   2. Bothersome early satiation
3. G-POEM
   1. The G-POEM procedure must have been performed at least 4 weeks prior to screening.
   2. GCSI score is < 3 which correlates to mild or less symptom severity.
4. Controls

None of the above conditions

1. Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics).
2. Gastrectomy, fundoplication, vagotomy, bariatric surgery, post-surgical cause of gastroparesis, or gastric stimulation device surgically implanted within the last year. Prior G-POEM procedure for gastroparesis is allowed for the group of post-G-POEM study subjects.
3. Dysphagia, swallowing disorder
4. Suspected bowel obstruction or perforation
5. Gastric or parenteral feeding within 4 weeks of screening
6. Pregnancy or nursing
7. History of an eating disorder within 2 years of screening
8. Recent history (within six months of screening) of Alcohol Use Disorder or Substance Use Disorder as defined in DSM-5.

9. Uncontrolled thyroid disease

   10. Unstable cardiac, respiratory, hepatic or renal disease 11. Evidence of uncontrolled blood glucose (including HbA1C >9 or metabolic crisis in past

   60 days).

   12. 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).

   13. Use of as needed or daily opioids within the past 1 month. 14. Pyloric injection of neurotoxins (e.g. botulinum type A or B) within 3 months of the

   Screening visit.

   15. Altered mental status (e.g., hepatic encephalopathy) that limits the ability to

   swallow a capsule

   16. Expected to have Magnetic Resonance Imaging (MRI) examination within 30 days. 17. No reliable contact information - no phone, no permanent address. 18. Pacemaker or ICD 19. Inability to avoid using the bathroom for urination and/or bowel movements for the

   duration of the study.

   20. Metal Implant (ie metal hip arthroplasty, surgical mesh, coronary or arterial stent) 21. Prior bowel surgery 22. Severe claustrophobia 23. 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.