Clinical trial · Interventional
Microwave Intervention Under Local Anesthesia
Prospective Study Evaluating the Feasibility of Focal Microwave Ablation Under Local Anesthesia in Patients With Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localised Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Anesthesia (lidocaine hydrochloride) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Local Anesthesia
- description
- Patient undergoing the focal targeted microwave ablation procedure performed under local anesthesia using the Koelis TMA®
- interventionNames
- Procedure: Local Anesthesia (lidocaine hydrochloride)
Primary outcomes (1)
- measure
- Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer
- timeFrame
- Day 0 - Intervention
- description
- Feasibility will be assessed by the rate of complete procedure performed under local anesthesia, defined as the proportion of patients in whom the procedure is completed under local anesthesia without the unplanned use of general anesthesia or sedation or premature termination of treatment
Secondary outcomes (11)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available