Microwave Intervention Under Local Anesthesia

NCT07412275 | Not Yet Recruiting

• 2 other identifiers: MILA2026-A00095-46
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Localised prostate cancer; TMA; Local anesthesia; Koelis

Outcome Measures

Primary Outcomes (1)

• Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer

  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

  Day 0 - Intervention

Secondary Outcomes (11)

• Immediate Patient satisfaction regarding the procedure under local anesthesia

  Day 0 - Intervention

• 1 month patient satisfaction regarding the procedure under local anesthesia

  1 month

• Ease of performing the procedure from the operator's point of view

  Day 0 - Intervention

• Patient's level of pain at the time of administration of local anesthesia

  Day 0 - Intervention

• Patient's pain level during the TMA treatment,

  Day 0 - Intervention

Study Arms (1)

Local Anesthesia

EXPERIMENTAL

Patient undergoing the focal targeted microwave ablation procedure performed under local anesthesia using the Koelis TMA®

Procedure: Local Anesthesia (lidocaine hydrochloride)

Interventions

Local Anesthesia (lidocaine hydrochloride) PROCEDURE

Participants will receive the focal treatment performed with Koelis TMA® under local anesthesia

Local Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient affiliated to a social security scheme or beneficiary of such a scheme in accordance with the regulations in force.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koelis: lead

Study Sites (2)

Institut Jules Bordet

Brussels, 1070, Belgium

Location

Hôpital Cochin Port Royal

Paris, 75014, France

Location

MeSH Terms

Interventions

Anesthesia, Local; Lidocaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• ANRACT Julien, MD

  APHP - Hôpital Cochin Port Royal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JOSSAN Claire

CONTACT

+33 (0)7 85 05 40 23; claire.jossan@koelis.com

JOFFRAY Eloïse

CONTACT

+ 33 (0)6 32 60 41 80; eloise.joffray@koelis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is exploratory in nature. Given its feasibility design, no formal sample size calculation has been performed, and a total of 20 patients are planned to be included.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (1)