PillBot™ - Remotely Controlled Capsule Endoscopy

Feasibility and Safety of PillBot™ - Remotely Controlled Capsule Endoscopy: A Feasibility Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Disease
• Intervention / Treatment: Device: PillBot

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PillBot; Patient will swallow the PillBot and be assessed with EGD after two hours of the examination	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint	Adverse events rate during and following device use.	Up to two weeks
Primary Effectiveness Endpoint	Identification of the gastric anatomy landmarks (cardia, fundus, body, angulus, antrum, and pylorus) with PillBot compared to conventional endoscopy.	Through study completion, an average of two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Study Endpoints	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.	Through study completion, an average of two weeks
Secondary Study Endpoints	2. Accuracy of gastric lesions detection by the RCE compared to the upper endoscopy based on independent reviewer's assessment.	Through study completion, an average of two weeks

Collaborators and Investigators

• Sponsor: Endiatx

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases
• Other Study ID Numbers: Endiatx

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No