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

Not Applicable

Completed

• Conditions: Any Gastric Condition Which Requires Capsule Endoscopy

• Registration Number: NCT02775708
• Lead Sponsor: Medtronic - MITG

Brief Summary

The purpose of this study is to support development of PillCam Endoscopy System applications.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Status Verified: 2017-09
• Primary Completion: 2017-09-19
• Study Completion: 2017-10-24
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of gaps in the RAPID video will be assessed	capsule endoscopy procedure day

Trial Locations

Locations (2)

Klinikum Furth; 🇩🇪 Furth, Germany

Hospital De Navarra; 🇪🇸 Pamplona, Navarra, Spain