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Microwave treatment of prostate cancer using only local anesthesia

Tests whether focal microwave ablation can be done under local anesthesia in localized prostate cancer.

Plain-language title generated from the registry record
Registry title: Microwave Intervention Under Local Anesthesia

Key facts

Where
Brussels, BelgiumSee the site

Where in Belgium

  • Institut Jules BordetBrussels, BelgiumNo longer taking part

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  4. What happens if I want to stop?
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Trial details

Who runs it
Koelis
Trial code
NCT07412275
Record updated
19 May 2026
Original description
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.Read full original descriptionShow less

Prospective Study Evaluating the Feasibility of Focal Microwave Ablation Under Local Anesthesia in Patients With Localized Prostate Cancer

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.

Inclusion: 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: 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; Uncontrolled coagulopathies or bleeding disorder; Ineligibility for a Koelis TMA® intervention; Contraindication to general anesthesia and deep sedation; 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.

ClinicalTrials.gov NCT07412275