Идёт набор NCT07291973

Clinical Investigation Evaluating the Performance, Safety and Clinical Benefit of the Endowave FlexAblate™ Microwave Ablation System in Patients Undergoing Lung Ablation Procedures.

Без фазы С лечением Lung 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: Microwave Ablation.
Кому может быть актуально: Состояния в реестре: Lung Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Clinical Investigation in lUng canceR of the Endowave FlexAblate™ Microwave tRansbronchial Ablation System.

Обзор

The goal of this clinical trial is to learn if the FlexAblate™ Ablation System works to treat a lung cancer nodules and it will also learn about the safety of the ablation system. Participants in this clinical trial will be patients aged over 18 years who have been previously diagnosed with cancer in the lung (primary or secondary malignant tumours) and deemed unsuitable for surgery or are declining surgery or, patients suitable for microwave ablation procedure based on clinical assessment. Those who meet all of the eligibility criteria at a screening assessment (a review of eligibility to participate in the study includes review of information on the cancerous nodule, recording your medical history, current medications, a blood test, and quality of life assessments) will undergo the ablation treatment with FlexAblate™ Microwave Ablation System. Follow-up assessments will be at week 1 and months 1, 3, 6 and 12 will includes CT Scans (CT or "CAT" scan is a computed tomography scan), blood tests, assessment of overall health and quality of life assessments.

Подробное описание

This is a prospective, single-arm, non-randomised clinical investigation. Up to 43 subjects will be enrolled from up to 5 sites. The clinical investigation is designed to evaluate the performance and safety of the Endowave FlexAblate™ Microwave Ablation System device in subjects undergoing lung ablation procedures. Microwave Ablation System device in subjects undergoing lung ablation procedures.

Вмешательства

Устройство Microwave Ablation
FlexAblate Microwave Transbronchial Ablation System

Первичные конечные точки

Technical Efficacy [Срок оценки: 1 month]

Вторичные конечные точки (7)

Procedure Technical Success [Срок оценки: Day of procedure]
Ablation Technical Success [Срок оценки: At Discharge - Day 1]
Safety Assessment - number of device or procedure related Serious Adverse Events [Срок оценки: Through to 1 month follow-up]
Safety Assessment - number of device or procedure related Adverse Events (AE) [Срок оценки: Through to 3 months]
Quality of Life Assessment - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C30) [Срок оценки: 12 months]
Quality of Life Assessment - EQ-5D-5L health-related quality of life questionnaire [Срок оценки: 12 months]
Quality of Life Assessment - Bronchoscopic Ablation Patient Pain and Satisfaction Survey [Срок оценки: 1 month]

Критерии участия

Критерии включения

Adult ≥ 18 years of age who has provided signed informed consent.
Subject is able and willing to comply with the planned clinical investigation follow-up schedule
Pathological confirmed malignant nodule in the lung either primary or metastatic disease.
Target nodule is ≤ 20mm in maximum diameter.
There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure.
Subject is a candidate for an elective lung ablation procedure as determined by institutional multi-disciplinary board or equivalent.
Subject or the lesion is not suitable for surgery or patient refuses surgery.

Критерии исключения

Target nodule is abutting main or lobar stem bronchus, main pulmonary vasculature (vessel 5mm), heart, oesophagus and/or trachea.
Subjects who are extremely breathless or on home oxygen therapy.
Female subjects who are pregnant or nursing.
Subjects with uncorrectable coagulopathy or thrombocytopenia at time of screening.
Subjects with prior pneumonectomy.
Subjects who have had any radiation (i.e., SBRT or EBRT) to the intended ablation zone or lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned ablation procedure or those who plan to receive a lung ablation, surgical resection, or radiation therapy on the ablated lung side before completing the primary endpoint assessment (30 days post-ablation).
Subjects who have implantable electronic devices, including pacemakers or other electronic implants.
Known pulmonary hypertension (Pulmonary artery systolic pressure, PASP >50mmHg).
Active active pulmonary infection at time of screening or the procedure.
Subjects medically unable to stop anticoagulant or anti-platelet therapy for relevant time period prior to and following the ablation procedure.
Participation in an investigational drug or device clinical investigation within 30 days of enrolment that would interfere with this clinical investigation.
The investigator determines that participation in this clinical investigation may jeopardise the safety or welfare of the subject.

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

Здоровые добровольцы: Нет