NCT Number: NCT02775708
Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance
The purpose of this study is to support development of PillCam Endoscopy System applications.
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Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Klinikum Furth, Fürth, Germany
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Number of gaps in the RAPID video will be assessed
Time frame: capsule endoscopy procedure day
Sponsors and collaborators
Lead sponsor
Medtronic - MITG
Industry
Registry information
Acronym: NOISE
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- May 18, 2016
- Registry last updated
- Nov 1, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.