Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance
Not Applicable
Completed
- Conditions
- Any Gastric Condition Which Requires Capsule Endoscopy
- Interventions
- Device: Pillcam endoscopy system
- 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
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
- Arm && Interventions
Group Intervention Description capsule endoscopy Pillcam endoscopy system open label arm ; up to 100 subjects indicated for capsule endoscopy (CE) procedure will undergo the CE procedure with the Pillcam endoscopy system
- Primary Outcome Measures
Name Time Method Number of gaps in the RAPID video will be assessed capsule endoscopy procedure day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Klinikum Furth
🇩🇪Furth, Germany
Hospital De Navarra
🇪🇸Pamplona, Navarra, Spain