Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03894553
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2018-11-12
Brief Title:
Focused Ultrasound FUS Mesencephalotomy for Head Neck Cancer Pain
Sponsor:
Jeff Elias MD
Organization:
University of Virginia
Study Overview
Official Title:
Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy for Pain Palliation in Head Neck Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This proposed pilot study will investigate the safety and initial effectiveness of focused ultrasound lesioning of the contralateral mesencephalon for severe opioid-resistant pain associated with head and neck cancer
Detailed Description:
This pilot study is designed as a prospective open-label clinical trial of stereotactic FUS mesencephalotomy in 6 subjects with treatment-refractory pain from head and neck cancer Primary safety assessments will be made throughout the study period of 6 months following the procedure Primary efficacy outcome is determined by comparing the difference in baseline NPRS to 3 months post treatment All subjects receiving treatment will be followed for the six month study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None