Microwave Intervention Under Local Anesthesia

This clinical investigation is a prospective feasibility study designed 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. Koelis TMA® is a CE-marked medical device use without any modification to the device's intended use.

The study will be conducted in a routine clinical care setting. Eligible patients requiring the procedure will be included after providing informed consent.

The study consists of four visits. At the inclusion visit (Visit 0), patient eligibility will be confirmed and baseline data will be collected. The intervention will be performed during Visit 1 under local anesthesia according to standard clinical practice. A follow-up phone call (Visit 2) will be conducted 7 days after the procedure (±2 days) to assess safety and tolerability data. The end-of-study visit (Visit 3) will take place 1 month after the intervention (±7 days) during a routine follow-up consultation.

The primary objective of the study is to assess the feasibility of performing the procedure under local anesthesia. Feasibility will be evaluated by the proportion of patients in whom the procedure is successfully completed under local anesthesia. If the patient presents marked discomfort, pain, or any other symptoms that make the continuation of the procedure inappropriate, it may be interrupted at his request or at the initiative of the investigator. Local anesthesia can therefore be converted to general anesthesia or deep sedation to allow treatment to continue.

Secondary objectives include the assessment of procedure tolerability, safety, ease of performance as assessed by the operator, patient satisfaction related to anesthesia, and the amount of analgesic or pain medication administered during the study period.

Inclusion criteria

• 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.

Exclusion criteria

• 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.