Trials / Terminated
TerminatedNCT02225223
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation Prior to or Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) [The STARRT Study]
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Merit Medical Systems, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.
Detailed description
Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and "No Previous RT"
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | STAR™ Tumor Ablation System | Targeted-radiofrequency ablation (t-RFA) |
| DEVICE | StabiliT® Vertebral Augmentation System | Radiofrequency-targeted vertebral augmentation (RF-TVA) |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2014-08-26
- Last updated
- 2021-08-11
- Results posted
- 2021-07-21
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02225223. Inclusion in this directory is not an endorsement.