Bipolar RFA of Painful Extra-spinal Bone Metastases

NCT ID: NCT03738670

Last Updated: 2024-08-29

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2023-10-06

Brief Summary

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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.

Detailed Description

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Conditions

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Multi-metastatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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RFA

Single-arm prospective observational study

Group Type EXPERIMENTAL

Percutaneous RFA

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Other Identifiers

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7010

Identifier Type: -

Identifier Source: org_study_id

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