Microwave Intervention Under Local Anesthesia

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.

NCT Number	NCT07412275
Lead Sponsor	Koelis
Conditions	Localised Prostate Cancer
Enrollment	20 participants
Start Date	2026-06-15
Primary Completion	2027-05-15 (estimated)
Study Completion	2027-06-15 (estimated)
Updated on ClinicalTrials.gov	2026-05-19