A Phase 1 interventional study of Cryoablation in Pain and Neoplasm Metastasis, sponsored by Boston Scientific Corporation. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-16.
Sponsored by Boston Scientific Corporation · Phase 1, Interventional, and Supportive care
This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.
Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy will be offered enrollment into the study. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).
Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 29 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects will have cryoablation on one or two painful metastatic bone tumors.
Procedure: Cryoablation
For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.
Also known as: Cryotherapy, Cryosurgery, Visual-ICE Cryoablation System, SeedNet Cryoablation System, PresIce Cryoablation System, IceRod Cryoablation Needle, IceRod PLUS Cryoablation Needle, IceEDGE 2.4 Cryoablation Needle, IceSeed Cryoablation Needle, IceSphere Cryoablation Needle
Difference in worst pain scores
The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.
Time frame: 24 weeks post-cryoablation
Cryoablation retreatments
If the first cryoablation procedure effectively relieves pain but the relief wears off over time and the pain becomes unbearable, a second procedure may be performed. The number of repeat cryoablation treatments will be recorded.
Time frame: 24 weeks post-cryoablation
Additional surgical treatments other than cryoablation
If pain is not effectively relieved by the cryoablation, other surgical treatments may be performed. The number of these treatments will be recorded.
Time frame: 24 weeks post-cryoablation
Reduced analgesic usage
The number of subjects (percentage) who are able to reduce analgesic medications from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation will be recorded.
Time frame: 24 weeks post-cryoablation
Time to maximal palliation of pain after cryoablation
The difference in pain scores will be assessed from baseline to follow-up intervals after cryoablation will be analyzed. The interval indicating the most relief from pain will be compared across subjects.
Time frame: 24 weeks post-cryoablation
Subject satisfaction with the amount palliation of pain obtained from cryoablation
Subject satisfaction will be compared at baseline to follow-up intervals.
Time frame: 24 weeks post-cryoablation
Number of adverse events
The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure.
Time frame: 30 days post-cryoablation
Difference in average pain scores
Difference in average pain scores from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation as measured on the numeric 0 to 10 BPI scale
Time frame: 24 weeks post-cryoablation
Time to recurrence of worst pain
Time to recurrence of worst pain at or above baseline; worst pain score in the 24 week follow-up period as measured on the numeric 0 to 10 BPI scale
Time frame: 24 weks post-cryoablation
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Boston Scientific Corporation