Набор скоро начнётся NCT07412275

Microwave Intervention Under Local Anesthesia

Без фазы С лечением Localised Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Local Anesthesia (lidocaine hydrochloride).
Кому может быть актуально: Состояния в реестре: Localised Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия, Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Feasibility of focal TMA therapy under local anesthesia in patients with localized prostate cancer [Срок оценки: Day 0 - Intervention]

Вторичные конечные точки (11)

Immediate Patient satisfaction regarding the procedure under local anesthesia [Срок оценки: Day 0 - Intervention]
1 month patient satisfaction regarding the procedure under local anesthesia [Срок оценки: 1 month]
Ease of performing the procedure from the operator's point of view [Срок оценки: Day 0 - Intervention]
Patient's level of pain at the time of administration of local anesthesia [Срок оценки: Day 0 - Intervention]
Patient's pain level during the TMA treatment, [Срок оценки: Day 0 - Intervention]
To assess the patient's level of pain after treatment, [Срок оценки: Day 0 - Intervention]
To evaluate the duration of the different stages of the procedure, [Срок оценки: Day 0 - Intervention]
Success of the completion of the procedure [Срок оценки: Day 0 - Intervention]
Feasibility of performing a TMA procedure in ambulatory setting [Срок оценки: Day 0 - Intervention]
Tolerance of performing the procedure under local anesthesia, [Срок оценки: 1 month]
Amount of medication received by the patient [Срок оценки: 1 month]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет