NCT07412275

Microwave Intervention Under Local Anesthesia

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Koelis · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical investigation is a prospective feasibility study designed 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. Koelis TMA® is a CE-marked medical device use without any modification to the device's intended use. The study will be conducted in a routine clinical care setting. Eligible patients requiring the procedure will be included after providing informed consent. The study consists of four visits. At the inclusion visit (Visit 0), patient eligibility will be confirmed and baseline data will be collected. The intervention will be performed during Visit 1 under local anesthesia according to standard clinical practice. A follow-up phone call (Visit 2) will be conducted 7 days after the procedure (±2 days) to assess safety and tolerability data. The end-of-study visit (Visit 3) will take place 1 month after the intervention (±7 days) during a routine follow-up consultation. The primary objective of the study is to assess the feasibility of performing the procedure under local anesthesia. Feasibility will be evaluated by the proportion of patients in whom the procedure is successfully completed under local anesthesia. If the patient presents marked discomfort, pain, or any other symptoms that make the continuation of the procedure inappropriate, it may be interrupted at his request or at the initiative of the investigator. Local anesthesia can therefore be converted to general anesthesia or deep sedation to allow treatment to continue. Secondary objectives include the assessment of procedure tolerability, safety, ease of performance as assessed by the operator, patient satisfaction related to anesthesia, and the amount of analgesic or pain medication administered during the study period.

Conditions

• Localised Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Local Anesthesia (lidocaine hydrochloride)	Participants will receive the focal treatment performed with Koelis TMA® under local anesthesia

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

2 sites across 2 countries: Belgium, France