Trials / Completed
CompletedNCT01123512
The Kiva® System as a Vertebral Augmentation Treatment
The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Benvenue Medical, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vertebral augmentation | Vertebral augmentation for one or two osteoporotic vertebral compression fractures |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2010-05-14
- Last updated
- 2014-10-09
- Results posted
- 2014-08-21
Locations
21 sites across 5 countries: United States, Belgium, Canada, France, Germany
Source: ClinicalTrials.gov record NCT01123512. Inclusion in this directory is not an endorsement.