New device zaps spine tumor pain in clinical trial
NCT ID NCT05467540
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device called Spinery® that uses radio-frequency energy to treat painful tumors that have spread to the spine or nearby bones. 52 adults who could not have or did not benefit from standard treatments received the procedure. The goal was to see if the device safely reduces pain and improves quality of life over 12 months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
52 people
The number who actually took part.
- Started
-
Jul 2022
- Finished
-
Nov 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bone metastases are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Azienda Ospedaliera Antonio Cardarelli
Naples, Italy
-
Azienda Ospedaliera Universitaria Senese
Siena, Italy
-
Azienda Ospedaliera di Cosenza
Cosenza, Italy
-
Istituto Oncologico del Mediterraneo IOM
Catania, Italy
-
Ospedale Santissima Trinità
Cagliari, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can radiation boost a personalized prostate cancer vaccine?
- Preventive radiation may stop bone events before they start — a trial puts it to the test
- Can a new capsule ease bone metastasis pain without opioids?
- Hip muscle repair method may improve walking after bone cancer surgery
- New model aims to predict jaw bone disease before it strikes
- Could removing the primary tumor boost survival in stage IV breast cancer with Bone-Only spread?