Any Gastric Condition Which Requires Capsule Endoscopy Clinical Trial
— NOISEOfficial title:
Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance
| Verified date | September 2017 |
| Source | Medtronic - MITG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to support development of PillCam Endoscopy System applications.
| Status | Completed |
| Enrollment | 53 |
| Est. completion date | October 24, 2017 |
| Est. primary completion date | September 19, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum Furth | Furth | |
| Spain | Hospital De Navarra | Pamplona | Navarra |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic - MITG |
Germany, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of gaps in the RAPID video will be assessed | capsule endoscopy procedure day |