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
Qualifiers
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
Treatments tested in this trial
- Local Anesthesia (lidocaine hydrochloride)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov