NCT01833806

A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.

Detailed description

As part of the PMA # P110039 review process and approval, InSightec was requested to conduct a post-approval study. Patients will be treated following the approved commercial treatment guidelines. For this study, participating sites will use the ExAblate device for the administration of the ExAblate treatment. This study will be performed on either 1.5T or 3T MR scanners. For this study, a total of 70 patients meeting the approved commercial guidelines will be enrolled and treated with the ExAblate system at from 7 to 10 sites. The proportion of responders is expected to be at least 30% greater than the proportion of subjects experiencing pain progression (i.e., 60% vs. 30%). Additionally, at the 3 month visit, an analysis of both the safety and efficacy profiles will be compared to the original PMA pivotal study group.

Conditions

• Bone Metastasis

Interventions

Type	Name	Description
DEVICE	ExAblate MRgFUS	Focused Ultrasound Ablation

Timeline

• Start date: 2013-09-01
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2013-04-17
• Last updated: 2023-04-07
• Results posted: 2023-04-07

Locations

9 sites across 1 country: United States