Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance (NOISE)

October 30, 2017 updated by: Medtronic - MITG
The purpose of this study is to support development of PillCam Endoscopy System applications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Furth, Germany, 907766
        • Klinikum Fürth
  • Spain
    • Navarra
      • Pamplona, Navarra, Spain
        • Hospital de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject's from 18 years of age.
  • Subject is indicated for Capsule Endoscopy procedure.
  • Subject agrees to sign the Informed Consent Form.

Exclusion Criteria:

  • Female subject is pregnant.
  • Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
  • Subject has a pacemaker or other implanted electro-medical device.
  • Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
  • Subject suffers from life threatening conditions.
  • Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: capsule endoscopy
open label arm ; up to 100 subjects indicated for capsule endoscopy (CE) procedure will undergo the CE procedure with the Pillcam endoscopy system
Device: Pillcam endoscopy system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of gaps in the RAPID video will be assessed
Time Frame: capsule endoscopy procedure day
capsule endoscopy procedure day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

September 19, 2017

Study Completion (Actual)

October 24, 2017

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • COVGIRD0477

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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