Gastric Disease
Conditions
Brief summary
The PillBot System is an endoscopic capsule imaging system intended for visualization of the stomach. In contrast to currently used passive capsule endoscopy systems, and FDA cleared active magnetic system, the PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator
Interventions
DEVICEPillBot
The PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator.
Sponsors
Endiatx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Ability to provide written, informed consent to undergo both capsule endoscopy (un-sedated) and conventional OGD * Willing and able to complete study follow-up requirements * Patient has appropriate indications for upper endoscopy including symptoms of, but not limited to upper abdominal pain, acid reflux, heartburn, iron deficiency anemia, weight loss, bloating, belching, nausea, vomiting and atypical chest pain
Exclusion criteria
All patients who meet any of the following criteria should not be enrolled into the study: * Coagulopathy with INR \> 1.5, thrombocytopenia with platelet counts \< 50,000 * Active bleeding * Need for therapeutic procedures during endoscopy * Lactation * Dysphagia, or other swallowing disorders * Known esophageal diverticulum or stricture * Swallowing disorder * Known luminal, gastrointestinal strictures * Patient with Crohn's disease or other potential obstructive conditions, unless there is a recent Computed tomography enterography (CTE) or Magnetic resonance enterography (MRE), MRE or patency capsule performed to exclude an obstructive lesion that may retain the capsule * History of esophageal, gastric surgery or intestinal surgery * Esophageal or GI motility disorder * Known or suspected gastrointestinal obstruction, significant intestinal strictures, or fistulas based on the clinical picture or pre-procedure testing and profile. * Current participation in another investigational drug or device treatment study * Pregnant or wishes to become pregnant during the study follow-up period * Patient with implanted medical device that would be potentially affected radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators) * Severe psychiatric, neurological, cardio-vascular, or renal disorders * History of allergy or intolerance to materials used to make the PillBot
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | Up to two weeks | Adverse events rate during and following device use. |
| Primary Effectiveness Endpoint | Through study completion, an average of two weeks | Identification of the gastric anatomy landmarks (cardia, fundus, body, angulus, antrum, and pylorus) with PillBot compared to conventional endoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Study Endpoints | Through study completion, an average of two weeks | 1\. Complete gastric examination using PillBot and its passage into the duodenum. Complete gastric examination is defined as the ability to identify and distinguish lesion type (i.e., polyps, ulcers, submucosal humps, etc.), lesion size (e.g., \<5mm and \> 5mm) and location when using the PillBot compared with conventional endoscopy. |
Outcome results
None listed