PillBot™ - Remotely Controlled Capsule Endoscopy

NCT06212206 | Unknown

• 1 other identifier: Endiatx
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Secondary Study Endpoints

  Through study completion, an average of two weeks

• Secondary Study Endpoints

  Through study completion, an average of two weeks

Study Arms (1)

PillBot

EXPERIMENTAL

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

Device: PillBot

Interventions

PillBot 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.

PillBot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endiatx: lead

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 18, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01