Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2019-06-12
2023-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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RFA
Single-arm prospective observational study
Percutaneous RFA
Single session percutaneous extra-spinal bone metastasis destruction to achieve pain relief
Interventions
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Percutaneous RFA
Single session percutaneous extra-spinal bone metastasis destruction to achieve pain relief
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Luigi Roberto CAZZATO, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Strasbourg, France
Locations
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University Hospital, Strasbourg, france
Strasbourg, , France
Countries
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Other Identifiers
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7010
Identifier Type: -
Identifier Source: org_study_id
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