Clinical trial · Interventional
Bipolar RFA of Painful Extra-spinal Bone Metastases
Pain Evaluation After Treatment of Extra-spinal Bone Metastases With OsteoCOOL Radiofrequency (RF) Ablation System
NCT03738670CI-TRIAL-00080328PERFACOOLterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruitment difficulties
Summary
Brief summary (as posted)
To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multi-metastatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Percutaneous RFA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RFA
- description
- Single-arm prospective observational study
- interventionNames
- Procedure: Percutaneous RFA
Primary outcomes (1)
- measure
- Percentage of responding patients reporting an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire
- timeFrame
- 1 month
Secondary outcomes (4)
- measure
- Comparison of the mean scores of the items 3, 5, 9B and 8 of the BPI questionnaire between the baseline and 6-month follow-up
- timeFrame
- 6 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\) Multi-metastatic cancer patients with at least one painful lytic bone metastasis * 2\) Target lesion should correspond to a specific radiologic finding * 3\) At least a moderate pain produce by target lesion (4 on a scale of 0 to 10 over the prior 24 hours with or without pain killers intake) assessed during selection evaluation * 4\) Patients 18 years old * 5\) Able to give written consent * 6\) Life expectancy 1 months * 7\) Patient affiliated to the National Health Insurance system Exclusion Criteria: 1. Radiation therapy on the target tumor terminated \< 3 weeks before treatment 2. Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk 3. Any contra-indication for the procedure as stated by the radiologist related to patient's condition (e.g. cardiac pacemakers) making the procedure at unacceptable risk 4. Impaired haemostasis 5. Concurrent participation in other experimental studies that could affect endpoints of this study 6. Contraindication to any form of sedation/anaesthesia 7. Signs of local/systemic infection identified before procedure, in accordance with standard care 8. Sclerotic metastases 9. Adults under guardianship 10. Patients under judicial protection 11. Pregnant or breastfeeding woman
References
Publications (0)
Data not yet available
No reference posted for this study.