PillBot™ - Remotely Controlled Capsule Endoscopy

Not Applicable

Not yet recruiting

• Conditions: Gastric Disease
• Interventions: Device: PillBot

• Registration Number: NCT06212206
• Lead Sponsor: Endiatx

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-26
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18
• Study Start: 2024-05
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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