Trials / Completed
CompletedNCT02738840
A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.
Detailed description
The study will be performed as an international, multicenter, prospective and single-arm design. The study will be conducted as a Post Market Clinical Follow Up (PMCF) study and the results will be submitted to the Notified Body: BSI Group (BSI).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | MRI scan | MRI scan |
Timeline
- Start date
- 2016-10-21
- Primary completion
- 2020-12-01
- Completion
- 2020-12-02
- First posted
- 2016-04-14
- Last updated
- 2021-06-10
- Results posted
- 2021-05-24
Locations
10 sites across 7 countries: United States, Austria, Belgium, Germany, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02738840. Inclusion in this directory is not an endorsement.