Microwave Intervention Under Local Anesthesia
NCT07412275 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-05-19
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.
Conditions
- Localised Prostate Cancer
Interventions
- PROCEDURE
-
Local Anesthesia (lidocaine hydrochloride)
Participants will receive the focal treatment performed with Koelis TMA® under local anesthesia
Sponsors & Collaborators
-
Koelis
lead INDUSTRY
Principal Investigators
-
ANRACT Julien, MD · APHP - Hôpital Cochin Port Royal
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-15
- Primary Completion
- 2027-05-15
- Completion
- 2027-06-15
Countries
- Belgium
- France
Study Locations
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