NCT01448382

Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

1. Primary Scientific Objective * Collect human clinical data to sustain the development of blood detection sensor and optimize its algorithm and parameters * Preliminary evaluation of blood detection performances in human. 2. Secondary Scientific Objective * Assessment of blood detection sensor ability to identify the anatomical location (i.e. Stomach, SB or Colon) * Evaluation of capsule transit characteristics in the GI tract * Evaluation of BBC capsule safety Study Hypothesis: It is estimated that by implementing a spectrophotometer technology in capsule and utilizing the unique characteristics of light absorption by blood in specific spectrum, the capsule will be able to automatically detect blood in the GI tract with high accuracy. As such, the system may be an add-on to video capsules to provide efficient and quick detection of blood presence (for example in OGBI patients) or as stand alone low cost capsule (without video) which could serve as a tool similar to standard FOBT.

Detailed description

This study is designed to support the development of a novel blood sensing detector embedded in a PillCam® capsule and to provide initial evaluation of its performance in humans. The device is named Blood Sensing Capsule (BSC), and is based on the Given PillCam® Platform with a modified capsule.

Conditions

• Upper GI Bleeding

Interventions

Type	Name	Description
DEVICE	PillCam® capsule with Given PillCam® Platform	capsule endoscopy

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-10-07
• Last updated: 2019-07-31

Locations

1 site across 1 country: Israel