Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05467540
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-01
First Post:
2022-07-13
Brief Title:
SPINERY A Novel Radio-Frequency Tumor Ablation Device Study
Sponsor:
Axon srl
Organization:
Axon srl
Study Overview
Official Title:
Clinical Study of SPINERY A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
SPARTA
Brief Summary:
SPINERY is a Radiofrequency RF device designed for palliative treatment of patients with painful metastatic bone tumors involving vertebral bodies sacrum iliac crest and peri-acetabulum
In particular SPINERY is conceived for pain reduction in patients affected by metastatic bone tumors involving the vertebral bodies sacrum iliac crest and periacetabulum in patients with indication for Standard Therapy and in patients who have failed not candidates or refuse Standard Therapy
Primary objective of the SPARTA Study is to demonstrate that SPINERY RF device is effective in short-term 3 months pain reduction in patients affected by metastatic bone tumors and to demonstrate that SPINERY RF device is safe in the RF ablation treatment of metastatic bone tumors without causing device-related adverse events including in particular nerve injury
Primary objective hypothesis will be obtained with Brief Pain Inventory BPI scale performance questionnaire in terms of palliative treatment
Change of Worst Pain Score expressed as average reduction of 2 BPI Brief Pain Inventory scores will be calculated as
μc worst-pain 3-month - worst-pain baseline
A negative average value for change in pain represents a lowering of the subjects pain score an improvement or reduction in pain and a positive value represents an increase in the subjects pain score a worsening or increase in pain Worst pain score at the target treatment site will be collected from the BPI in the past 24 hours
In particular SPINERY is conceived for pain reduction in patients affected by metastatic bone tumors involving the vertebral bodies sacrum iliac crest and periacetabulum in patients with indication for Standard Therapy and in patients who have failed not candidates or refuse Standard Therapy
Primary objective of the SPARTA Study is to demonstrate that SPINERY RF device is effective in short-term 3 months pain reduction in patients affected by metastatic bone tumors and to demonstrate that SPINERY RF device is safe in the RF ablation treatment of metastatic bone tumors without causing device-related adverse events including in particular nerve injury
Primary objective hypothesis will be obtained with Brief Pain Inventory BPI scale performance questionnaire in terms of palliative treatment
Change of Worst Pain Score expressed as average reduction of 2 BPI Brief Pain Inventory scores will be calculated as
μc worst-pain 3-month - worst-pain baseline
A negative average value for change in pain represents a lowering of the subjects pain score an improvement or reduction in pain and a positive value represents an increase in the subjects pain score a worsening or increase in pain Worst pain score at the target treatment site will be collected from the BPI in the past 24 hours
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None