Trials / Completed
CompletedNCT01323543
Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine
"Elaspine™ Implant System Post Marketing Clinical Study: A Prospective, Multicentre Study to Evaluate the Safety and Performance of the Elaspine™ System in the Surgical Treatment of Degenerative Lumbar Spine"
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Spinelab AG · Industry
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The safety and performance of the Elaspine™ Implant System in the treatment of lower back pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing clinical study (PMCS). The study will be enrolled within Germany and Switzerland in 3-5 clinical centres, including in average 10 patients per centre. The study is conducted in accordance with the Standard ISO 14155, where applicable on clinical investigation of medical devices for human subjects and other legal requirements.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Elaspine™ | Implantation of device |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2011-03-25
- Last updated
- 2015-11-17
Locations
5 sites across 2 countries: Germany, Switzerland
Source: ClinicalTrials.gov record NCT01323543. Inclusion in this directory is not an endorsement.