Microwave Intervention Under Local Anesthesia
Starting soon · Not applicable
Conditions studied: Localised Prostate Cancer
In brief
This study aims to evaluate the feasibility of performing a focal Targeted Microwave Ablation (TMA) procedure using Koelis TMA® under local anesthesia in patient with localized prostate cancer. Eligible patients will undergo the procedure under local anesthesia instead of general anesthesia or deep sedation as part of their routine clinical care. The primary objective is to assess the feasibility of completing the procedure under local anesthesia, defined by the proportion of patients in whom the procedure is successfully completed under local anesthesia. Secondary objectives include the assessment of safety, ease of performance, patient satisfaction, and the use of analgesic medication. This study is designed as a feasibility clinical investigation conducted in a routine clinical practice setting.
Key facts
- Study ID
- NCT07412275
- Run by
- Koelis
- People needed
- 20
- Starts
- 2026-06-15
- Expected to finish
- 2027-06-15
- Last updated by the study team
- 2026-05-19
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Age>18 years old
- Patient undergoing Koelis TMA® intervention
- Patient is suitable for general, local anesthesia as well as sedation
- No psychiatric illness that would prevent informed consent or optimal treatment and follow-up
- Free, informed and written consent, dated and signed by the patient and the investigator, no later than the day of inclusion and before any examination required by the study.
- Patient affiliated to a social security scheme or beneficiary of such a scheme in accordance with the regulations in force.
You may not qualify if…
- Severe illness within the last 6 months before the screening visit, including any of the following: uncontrolled congestive heart failure, uncontrolled angina pectoris, myocardial infarction, stroke.
- Ineligibility for a Koelis TMA® intervention
- Contraindication to general anesthesia and deep sedation.
- Uncontrolled coagulopathies or bleeding disorder
- A person already participating in an interventional clinical study.
- A person placed under judicial protection, guardianship, or legal supervision and incapable of freely giving informed consent.
- Patient detained in an institution by medical or judicial decision.
Where it is running
- Institut Jules Bordet — Brussels, Belgium
- Hôpital Cochin Port Royal — Paris, France
Full record on ClinicalTrials.gov
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