Microwave Intervention Under Local Anesthesia (NCT07412275) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Microwave Intervention Under Local Anesthesia
Belgium, France20 participantsStarted 2026-06-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer