Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

Официальное название

Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

Обзор

The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation prior to surgery.

Подробное описание

This is a post-market, prospective, single-arm, multicentre, open-label, non-randomised study which will enrol up to 30 subjects in total (plus replacements if required due to drop out).

Prospective patients must have a histopathological-confirmed malignant lung lesion and be candidates for surgical resection. After being informed about the study and potential risks, all patients giving their written informed consent will undergo a screening visit to determine eligibility for study entry.

The study consists of two (2) stages (Stage A and Stage B). Stage A consists of the ablation and surgical resection being performed concurrently on Day 0 within a single procedure. Stage B consists of the ablation and the surgical resection being performed in separate procedures. The surgical resection will occur between Day 7 and Day 21, post-ablation, inclusive of those days. The aim is to follow local guidelines for treatment of lung cancer.

Patients undergoing Stage A will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).

Patients undergoing Stage B will have evaluations at follow-up visits conducted at 7 (+/-3) days (via phone call) post ablation and prior to the surgical resection procedure. Stage B patients will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).

Вмешательства

• Устройство Ablation
  Bronchoscopy and microwave ablation prior to surgical resection.

Первичные конечные точки

• Primary Safety Endpoint [Срок оценки: Day 0, day of ablation procedure up to initiation of surgical resection procedure.]
• Primary Safety Endpoint [Срок оценки: Day 7-21, post ablation procedure up to initiation of surgical resection procedure.]
• Primary Performance (Efficacy) Endpoint [Срок оценки: Up to 1 week post ablation procedure.]

Вторичные конечные точки (4)

• Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion [Срок оценки: Up to 1 week post ablation procedure.]
• Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT [Срок оценки: Up to 1 week post ablation procedure.]
• Secondary Performance (Efficacy) Endpoints - Procedural Time [Срок оценки: Up to 1 week post ablation procedure.]
• Secondary Performance (Efficacy) Endpoints - Assessment of ease of system use (clinician questionnaires) [Срок оценки: Up to 1 week post ablation procedure.]

Критерии участия

Критерии включения

Patients who:

• Have signed informed consent.
• Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
• Are ≥ 18 years old.
• Have lung lesion(s)/nodule(s) which are histopathological-confirmed as cancer.
• Have soft tissue lung lesion(s):

• ≤ 30 mm in the largest dimension of the pulmonary window for Stage A.
• ≤ 20 mm in the largest dimension of the pulmonary window for Stage B.
• Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
• Greater than 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
• Subject is willing and able to comply with the study protocol requirements.
• Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Критерии исключения

Patients who:

• Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic \& laryngeal nerves).
• Are pregnant or breast feeding, as determined by standard site practices.
• Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
• Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
• Have an expected survival less than 12 months.
• Have bleeding diathesis, uncorrectable coagulopathy, or platelet count ≤ 100 x 10\^9/L.
• Have an implantable device, including pacemakers or other electronic implants.
• Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] >50mmHg).
• Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can´t be stopped or temporarily withheld.
• Subject had a prior pneumonectomy.
• Diagnosis of Small Cell Lung Cancer.
• Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
• Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
• Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Amsterdam University Medical Centres, Location AMC, Meibergdreef 9 — Amsterdam

Публикации

• Covey AM, Gandhi R, Brody LA, Getrajdman G, Thaler HT, Brown KT. Factors associated with pneumothorax and pneumothorax requiring treatment after percutaneous lung biopsy in 443 consecutive patients. J Vasc Interv Radiol. 2004 May;15(5):479-83. doi: 10.1097/01.rvi.0000124951.24134.50. PMID 15126658
• Licker MJ, Widikker I, Robert J, Frey JG, Spiliopoulos A, Ellenberger C, Schweizer A, Tschopp JM. Operative mortality and respiratory complications after lung resection for cancer: impact of chronic obstructive pulmonary disease and time trends. Ann Thorac Surg. 2006 May;81(5):1830-7. doi: 10.1016/j.athoracsur.2005.11.048. PMID 16631680
• Boffa DJ, Allen MS, Grab JD, Gaissert HA, Harpole DH, Wright CD. Data from The Society of Thoracic Surgeons General Thoracic Surgery database: the surgical management of primary lung tumors. J Thorac Cardiovasc Surg. 2008 Feb;135(2):247-54. doi: 10.1016/j.jtcvs.2007.07.060. Epub 2007 Dec 21. PMID 18242243
• Chen H, Senan S, Nossent EJ, Boldt RG, Warner A, Palma DA, Louie AV. Treatment-Related Toxicity in Patients With Early-Stage Non-Small Cell Lung Cancer and Coexisting Interstitial Lung Disease: A Systematic Review. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):622-631. doi: 10.1016/j.ijrobp.2017.03.010. Epub 2017 Mar 15. PMID 28581404
• SABR UK Consortium. "Stereotactic Ablative Body Radiation Therapy (SABR): A Resource." Version 6.1. January 2019
• Chang et al The Lancet Oncology 2015 Vol 16, Issue 6, 630 - 637

Идентификаторы

NCT: NCT06689488 · PD-GTD-AB1-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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