Clinical trial NCT05467540: SPINERY™ A Novel Radio-Frequency Tumor Ablation Device Study
Official title: Clinical Study of SPINERY™ A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vertebral Metastasis
Lead sponsor: Axon srl
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Multicenter, no control group
Primary purpose: TREATMENT

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 subject's pain score (an improvement, or reduction in pain) and a positive value represents an increase in the subject's 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.


Eligibility criteria: Inclusion Criteria:

* Patients with painful metastatic malignant lesions involving bone;
* Patients, candidates to standard therapy, in which the RF ablation can be performed in combination with the Standard Therapy in accordance with the Investigator's indications;
* Patients who have failed, not candidates or refuse Standard Therapy (chemotherapy or radiotherapy);
* Patients with metastatic tumor size compatible with the expected ablation dimensions as reported for SPINERY devices in the IFU;
* Patients with localized pain resulting from not more than two sites of symptomatic metastatic disease
* Patients that do not have evidence of impending fracture
* Patients with metastatic lesions targeted for treatment located in the thoracic and/or lumbar vertebral body(ies), peri-acetabulum, iliac crest, and/or sacrum - no restrictions on location of lesion;
* Patients with BPI-Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
* Patients with Karnofsky score ≥ 40 at enrollment
* Patients willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
* Patients at least 18 years old at the time of informed consent

Exclusion Criteria:

* Patients implanted with heart pacemaker or other implanted electronic device
* Patients with previous mechanical bone stabilization in the vertebral body to be treated
* Use of SPINERY in vertebral body levels C1-C7
* Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone.
* Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection.
* Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise.
* Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression.
* Fractures due to prostatic cancer or other osteoblastic metastases to the spine. Metastatic lesions originating in the prostate that are osteolytic or of mixed origin are eligible for the study.
* Pregnant, breastfeeding, or plan to become pregnant during the study duration.
* Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
* Any condition that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation.

Primary outcomes:
measure: Change of Worst Pain Score of Brief Pain Inventory (BPI) scale performance is being assessed
timeFrame: Baseline, 3 months
measure: Completion (%) of the ablation procedure
timeFrame: Immediately after the procedure, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Ospedale Santissima Trinità
city: Catania
country: Italy
facility: Istituto Oncologico del Mediterraneo IOM
city: Cosenza
country: Italy
facility: Azienda Ospedaliera di Cosenza
city: Naples
country: Italy
facility: Azienda Ospedaliera Antonio Cardarelli
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
Study officials:
References: