PillBot™ - Remotely Controlled Capsule Endoscopy

Endiatx

Status

Not yet enrolling

Conditions

Gastric Disease

Treatments

Device: PillBot

Study type

Interventional

Funder types

Industry

Identifiers

NCT06212206

Endiatx

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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