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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Upper GI Bleeding

Clinical Trial Details

NCT number	NCT01448382
Study type	Interventional
Source	Medtronic - MITG
Contact
Status	Terminated
Phase	Phase 1
Start date	October 2011
Completion date	December 2015

View Details

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