Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New device zaps spine tumor pain in clinical trial

NCT ID NCT05467540

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Vår säkerhetsrekommendation!

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.