Trial Outcomes & Findings for Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors (NCT NCT05467540)

Last Updated: 2025-11-28

Results Overview

Pain severity and health-related quality of life were evaluated using two validated questionnaires: * Brief Pain Inventory (BPI): Participants rated their worst pain in the last 24 hours for each treated lesion site (thoracic, lumbar, peri-acetabulum, iliac crest, sacrum) on an 11-point numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate worse pain. The change in BPI Worst Pain Score was calculated as the average reduction from baseline to the 3-month visit. * EQ-5D-5L: Participants reported their overall health status across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on five levels of severity. Responses were converted into a utility index ranging from -0.594 (worst health state) to 1.000 (best health state), where higher scores indicate better quality of life. The EQ-5D-5L visual analogue scale (VAS) ranges from 0 (worst imaginable health) to 100 (best imaginable health).

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Baseline and 3-month follow-up

Results posted on

2025-11-28

Participant Flow

Participants were recruited between July 2022 and Nov 2023 at 5 clinical sites. Eligible participants were adult who met all inclusion/exclusion criteria specified in the protocol. Recruitment followed standard informed consent procedures at each site.

The Protocol Enrollment was 52 as planned. One participant withdrew consent after enrollment and prior to treatment allocation; therefore, 51 participants actually started the Spinery RF Ablation procedure. This explains the discrepancy between Protocol Enrollment and Started counts.

Participant milestones

Participant milestones
Measure	Spinery RF Ablation Treatment Group This is a single-arm interventional group in which all enrolled patients receive treatment with the Spinery® RF Generator in combination with its sterile single-use accessories (Spinery® Kit and Spinery® Cooling Connection). The investigational device delivers bipolar cooled radiofrequency (RF) energy to spinal metastatic lesions with the objective of achieving thermal ablation of the tumor and palliative pain relief. Under image guidance (e.g., fluoroscopy or CT), one or two bipolar cooled probes are percutaneously inserted into the target lesion (vertebral bodies, sacrum, iliac crest, or peri-acetabulum). The RF ablation is performed with energy delivery up to 20 minutes per lesion, with optional cement injection. The treatment is intended for patients who failed, are not candidates for, or refuse standard therapy. This arm evaluates the safety, short-term (3 months) and long-term (12 months) efficacy of the RF treatment in reducing pain, as well as procedural performance and usability. All participants are assessed at baseline and followed up at 1, 3, 6, and 12 months.
BaseLine STARTED	51
BaseLine COMPLETED	51
BaseLine NOT COMPLETED	0
3-Month Follow-up STARTED	51
3-Month Follow-up COMPLETED	41
3-Month Follow-up NOT COMPLETED	10
12-Month Follow-up STARTED	41
12-Month Follow-up COMPLETED	26
12-Month Follow-up NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Spinery RF Ablation Treatment Group This is a single-arm interventional group in which all enrolled patients receive treatment with the Spinery® RF Generator in combination with its sterile single-use accessories (Spinery® Kit and Spinery® Cooling Connection). The investigational device delivers bipolar cooled radiofrequency (RF) energy to spinal metastatic lesions with the objective of achieving thermal ablation of the tumor and palliative pain relief. Under image guidance (e.g., fluoroscopy or CT), one or two bipolar cooled probes are percutaneously inserted into the target lesion (vertebral bodies, sacrum, iliac crest, or peri-acetabulum). The RF ablation is performed with energy delivery up to 20 minutes per lesion, with optional cement injection. The treatment is intended for patients who failed, are not candidates for, or refuse standard therapy. This arm evaluates the safety, short-term (3 months) and long-term (12 months) efficacy of the RF treatment in reducing pain, as well as procedural performance and usability. All participants are assessed at baseline and followed up at 1, 3, 6, and 12 months.
3-Month Follow-up Withdrawal by Subject	1
3-Month Follow-up Lost to Follow-up	4
3-Month Follow-up Death	5
12-Month Follow-up Lost to Follow-up	6
12-Month Follow-up Death	8
12-Month Follow-up Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BaseLine n=51 Participants This single-arm group includes all patients enrolled and treated with the Spinery® RF Generator in combination with its sterile, single-use accessories (Spinery® Kit and Spinery® Cooling Connection). Each participant received radiofrequency (RF) ablation therapy targeted at bone metastatic lesions located in the vertebral bodies, sacrum, iliac crest, or peri-acetabulum. All procedures were image-guided and performed according to the protocol-defined treatment algorithm. Baseline demographic and clinical characteristics were collected before the ablation procedure and used to evaluate treatment efficacy and safety over time.
Age, Categorical <=18 years	0 Participants n=51 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=51 Participants
Age, Categorical >=65 years	27 Participants n=51 Participants
Sex: Female, Male Female	31 Participants n=51 Participants
Sex: Female, Male Male	20 Participants n=51 Participants
Primary Tumor Site Breast	19 participants n=51 Participants
Primary Tumor Site Lungs	12 participants n=51 Participants
Primary Tumor Site Prostate	4 participants n=51 Participants
Primary Tumor Site Bladder	1 participants n=51 Participants
Primary Tumor Site Kidney	4 participants n=51 Participants
Primary Tumor Site Colon	1 participants n=51 Participants
Primary Tumor Site Lynphatic system	1 participants n=51 Participants
Primary Tumor Site Lymphomas	1 participants n=51 Participants
Primary Tumor Site Sarcoma	1 participants n=51 Participants
Primary Tumor Site Adeno Carcinoma	1 participants n=51 Participants
Primary Tumor Site Intestine	1 participants n=51 Participants
Primary Tumor Site Chest	1 participants n=51 Participants
Primary Tumor Site Liver	1 participants n=51 Participants
Primary Tumor Site Pancreas	1 participants n=51 Participants
Primary Tumor Site Other	1 participants n=51 Participants
Target Lesion Location Vertebral Body	27 Participants n=51 Participants
Target Lesion Location Sacrum	10 Participants n=51 Participants
Target Lesion Location Iliac Crest	7 Participants n=51 Participants
Target Lesion Location Pari-acetabulum	7 Participants n=51 Participants
Pain Score at Baseline (BPI)	7.8 units on a scale STANDARD_DEVIATION 1.6 • n=51 Participants
EQ-5D-5L	42.8 units on a scale STANDARD_DEVIATION 16.8 • n=51 Participants

PRIMARY outcome

Timeframe: Baseline and 3-month follow-up

Population: All participants who started treatment and completed the 3-month follow-up visit are included in this analysis.

Outcome measures

Outcome measures
Measure	3-Months Follow-up n=41 Participants This group includes all participants who completed the 3-month follow-up visit after Spinery RF Ablation treatment.
Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires Change in Worst Pain Score (BPI, 0-10 scale; higher = worse pain)	3.4 points on a numeric scale Standard Deviation 2.8
Change From Baseline in Worst Pain and Quality of Life Scores at 3 Months Using the Brief Pain Inventory (BPI) and EQ-5D-5L Questionnaires Change in Quality of Life (EQ-5D-5L VAS, 0-100 scale; higher = better health status)	65.2 points on a numeric scale Standard Deviation 19.0

PRIMARY outcome

Timeframe: Post-Procedure (primary evaluation point)

Population: All participants who started treatment and were evaluated for procedural completion.

The number and percentage of participants who successfully completed the Spinery® RF ablation procedure per protocol. Completion is defined as participants who underwent the full planned treatment without premature discontinuation or technical interruption. Results are expressed as the count and percentage of the total number of treated participants.

Outcome measures

Outcome measures
Measure	3-Months Follow-up n=51 Participants This group includes all participants who completed the 3-month follow-up visit after Spinery RF Ablation treatment.
Number and Percentage of Participants Who Successfully Completed the Spinery® RF Ablation Procedure	51 Participants

Adverse Events

All Participants

Serious events: 13 serious events

Other events: 1 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=51 participants at risk This group includes all participants who underwent the Spinery® RF Ablation procedure with the Spinery® RF Generator and its sterile accessories. Adverse events were collected systematically at each clinical visit and via patient contact. Serious and non-serious procedure- or device-related adverse events were monitored from the day of the procedure through the 3-month follow-up visit. All-Cause Mortality was assessed from the day of the procedure through the 12-month follow-up visit. Events were evaluated for severity, seriousness, and relatedness to the procedure or device, in accordance with ISO 14155:2020. No modifications to standard AE/SAE definitions were applied.
General disorders Death	25.5% 13/51 • Serious and Other (Not Including Serious) Adverse Events were assessed from the day of the Spinery® RF Ablation procedure through the 3-month follow-up visit. All-Cause Mortality was assessed from the day of the procedure through the 12-month follow-up visit. Serious and Other (Not Including Serious) Adverse Events were assessed from the day of the Spinery® RF Ablation procedure through the 3-month follow-up visit. All-Cause Mortality was assessed from the day of the procedure through the 12-month follow-up visit.

Other adverse events

Other adverse events
Measure	All Participants n=51 participants at risk This group includes all participants who underwent the Spinery® RF Ablation procedure with the Spinery® RF Generator and its sterile accessories. Adverse events were collected systematically at each clinical visit and via patient contact. Serious and non-serious procedure- or device-related adverse events were monitored from the day of the procedure through the 3-month follow-up visit. All-Cause Mortality was assessed from the day of the procedure through the 12-month follow-up visit. Events were evaluated for severity, seriousness, and relatedness to the procedure or device, in accordance with ISO 14155:2020. No modifications to standard AE/SAE definitions were applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New metastasis (right scapula)	2.0% 1/51 • Serious and Other (Not Including Serious) Adverse Events were assessed from the day of the Spinery® RF Ablation procedure through the 3-month follow-up visit. All-Cause Mortality was assessed from the day of the procedure through the 12-month follow-up visit. Serious and Other (Not Including Serious) Adverse Events were assessed from the day of the Spinery® RF Ablation procedure through the 3-month follow-up visit. All-Cause Mortality was assessed from the day of the procedure through the 12-month follow-up visit.

Additional Information

Dr. Prof. Mario Muto

AORN Cardarelli

Phone: +39800019774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place