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

NCT01448382 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-07-31

No results posted yet for this study

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.

Conditions

  • Upper GI Bleeding

Interventions

DEVICE

PillCam® capsule with Given PillCam® Platform

capsule endoscopy

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Yehuda Chowers, PhD. · Rambam Health Care Campus

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01448382 on ClinicalTrials.gov