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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device Microwave Ablation
  FlexAblate Microwave Transbronchial Ablation System

Primary outcome measures

• Technical Efficacy [Time frame: 1 month]

Secondary outcome measures (7)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 2 centers

• St. Bartholomew's Hospital — London
• University College London Hospitals NHS Foundation Trust — London

France · 1 center

• CMC Ambroise Paré - Hartmann — Paris

Identifiers

NCT: NCT07291973 · EDW-CID-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗