NCT02775708CompletedNot Applicable
Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medtronic - MITG
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Number of gaps in the RAPID video will be assessed
Study Overview
Brief Summary
The purpose of this study is to support development of PillCam Endoscopy System applications.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
capsule endoscopy
Experimental
open label arm ; up to 100 subjects indicated for capsule endoscopy (CE) procedure will undergo the CE procedure with the Pillcam endoscopy system
Intervention: Pillcam endoscopy system (Device)
Outcomes
Primary Outcomes
Number of gaps in the RAPID video will be assessed
Time Frame: capsule endoscopy procedure day
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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