Microwave Intervention Under Local Anesthesia
ConditionLocalised Prostate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorKoelis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Local Anesthesia (lidocaine hydrochloride)
Procedure/SurgeryParticipants will receive the focal treatment performed with Koelis TMA® under local anesthesia
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Local AnesthesiaExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Day 0 - InterventionSecondary outcomes
1
Immediate Patient satisfaction regarding the procedure under local anesthesia
The patient's satisfaction regarding the TMA procedure will be assessed by a questionnaire after the procedure
Time frame
Day 0 - Intervention2
1 month patient satisfaction regarding the procedure under local anesthesia
The patient's satisfaction regarding the TMA procedure will be assessed by a questionnaire 1 month after the procedure
Time frame
1 month3
Ease of performing the procedure from the operator's point of view
The ease of performing the procedure will be evaluated by a score given by the operator (1: very easy; 2: easy; 3: moderate; 4: difficult, 5: very difficult).
Time frame
Day 0 - Intervention4
Patient's level of pain at the time of administration of local anesthesia
The patient's average pain level will be assessed during the administration of local anesthesia by a numerical pain rating scale from 0 to 10.
Time frame
Day 0 - Intervention Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: