Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility

Study Overview
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Brief Summary
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This is a feasibility study to assess the utility of magnetically controlled capsule endoscopy in the evaluation of gastroparesis and functional dyspepsia

Detailed Description
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Gastroparesis and functional dyspepsia can both present with abdominal pain, dyspepsia, nausea, emesis, or early satiety. Gastroparesis is a syndrome defined as delayed gastric emptying. Functional dyspepsia is a symptom-based diagnosis in which the pathophysiology is multifactorial. Delayed gastric emptying is present in 25-35% of patients with functional dyspepsia. The study investigators propose the Navicam magnetically controlled capsule endoscopy (MCCE) system as a potential new method of evaluating gastric motility disorders. The MCCE is FDA approved for visualization of the stomach. The ability to visualize gastric peristalsis in real time, without interference from an endoscope, has never been demonstrated. The MCCE system could allow physicians to evaluate gastric motility with a test that has clear advantages over the current methods: it is fast, non-invasive, and has no radiation exposure, has artificial intelligence (AI) capabilities, while at the same time provides a visual assessment of the gastric anatomy. In this pilot feasibility study, the study investigators plan to enroll 5 male and female adult healthy volunteers, 5 male and female patients with gastroparesis, 5 male and female patients with functional dyspepsia (epigastric pain syndrome and/or postprandial distress syndrome with or without gastric emptying delay), and 2 patients with gastroparesis who have undergone a G-POEM procedure. The study investigators will compare gastric motor patterns in the different sections of the stomach and symptoms during fasting and a sham meal between groups.

Official Title
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AnX/Ankon Navicam Magnetically Controlled Capsule Endoscopy Feasibility Study in Gastric Motility

Conditions
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Gastroparesis, Dyspepsia

Intervention / Treatment
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* Device: Magnetically Controlled Capsule Endoscopy


Participation Criteria
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Eligibility Criteria
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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 < 3 which correlates to mild or less symptom severity. Controls None of the above conditions Exclusion Criteria: 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). 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. Dysphagia, swallowing disorder Suspected bowel obstruction or perforation Gastric or parenteral feeding within 4 weeks of screening Pregnancy or nursing History of an eating disorder within 2 years of screening Recent history (within six months of screening) of Alcohol Use Disorder or Substance Use Disorder as defined in DSM-5. Uncontrolled thyroid disease Unstable cardiac, respiratory, hepatic or renal disease Evidence of uncontrolled blood glucose (including HbA1C >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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Four groups of participants will be studied: gastroparesis, functional dyspepsia, gastroparesis patients s/p G-POEM, and healthy controls.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>No diagnosis of gastroparesis, functional dyspepsia, or prior G-POEM | Device: Magnetically Controlled Capsule Endoscopy<br>* This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.<br>|
| Other: Gastroparesis<br>Patients with a diagnosis of gastroparesis meeting the inclusion criteria | Device: Magnetically Controlled Capsule Endoscopy<br>* This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.<br>|
| Other: Functional Dyspepsia<br>Patients with a diagnosis of functional dyspepsia meeting the inclusion criteria | Device: Magnetically Controlled Capsule Endoscopy<br>* This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.<br>|
| Other: G-POEM<br>Patients who received a G-POEM procedure meeting the inclusion criteria | Device: Magnetically Controlled Capsule Endoscopy<br>* This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and direction of contractions | Physiologic parameter measuring the frequency and direction of stomach contractions | Through study completion, an average of 1 year | 
| Number and location of luminal transit markers in the antrum, fundus, and overall | Physiologic parameter measuring the number and location of luminal transit markers in the stomach | Through study completion, an average of 1 year | 
| Largest diameter of the pylorus | Physiologic parameter measuring the diameter of the pylorus | Through study completion, an average of 1 year | 
| Dyspepsia Severity Scale symptom ratings at baseline and during the study at timepoints with discomfort if present. | Evaluating the dyspepsia Severity Scale symptom ratings (range of score 0-20) at baseline and during the study at timepoints with discomfort if present. | Through study completion, an average of 1 year | 
| Procedure related adverse events | Procedure related adverse events during or after the study session | Through study completion, an average of 1 year |