PillBot™ - Remotely Controlled Capsule Endoscopy

Gastric Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06212206
• Other study ID #: Endiatx
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Endiatx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Disease
• Stomach Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endiatx

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	Adverse events rate during and following device use.	Up to two weeks
Primary	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	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	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