PillBot™ - Remotely Controlled Capsule Endoscopy

NCT ID: NCT06212206

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2024-12-31

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

Conditions

Gastric Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PillBot

Patient will swallow the PillBot and be assessed with EGD after two hours of the examination

Group Type: EXPERIMENTAL

PillBot

Intervention Type: DEVICE

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

PillBot

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endiatx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Endiatx

Identifier Type: -

Identifier Source: org_study_id