Prospective Study Evaluating the Feasibility of Focal Microwave Ablation Under Local Anesthesia in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Koelis
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Local Anesthesia
Patient undergoing the focal targeted microwave ablation procedure performed under local anesthesia using the Koelis TMA®
干预措施: Local Anesthesia (lidocaine hydrochloride) (Procedure)
结局指标
主要结局
Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer
时间窗: Day 0 - Intervention
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
次要结局
- 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)
- To assess the patient's level of pain after treatment,(Day 0 - Intervention)
- To evaluate the duration of the different stages of the procedure,(Day 0 - Intervention)
- Success of the completion of the procedure(Day 0 - Intervention)
- Feasibility of performing a TMA procedure in ambulatory setting(Day 0 - Intervention)
- Tolerance of performing the procedure under local anesthesia,(1 month)
- Amount of medication received by the patient(1 month)