The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema

Официальное название

The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - A Pilot Study (CSP-12123)

Обзор

The goal of this clinical trial is to learn if bronchoscopic lung volume reduction with endobronchial thermal liquid ablation (ETLA) works to treat severe emphysema in terms of feasibility and safety. Participants will: * Have up to two ETLA procedures * Complete five clinic follow-up visits and two virtual follow-up visits.

Подробное описание

ETLA offers the potential to result in significant lung volume reduction of hyperinflated emphysematous regions, providing clinically meaningful improvement in pulmonary function and quality of life to a broad population of patients with severe emphysema. The REDUCE EU Pilot study will primarily evaluate the feasibility and safety of ETLA treatment in patients with severe emphysema. Secondarily, the study will evaluate the efficacy of sequential ETLA treatment.

Вмешательства

• Устройство Endobronchial Therman Liquid Ablation (ETLA)
  The ETLA System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted emphysematous lung regions with hyperinflation to cause tissue ablation and subsequent volume reduction as a means for treating emphysema. The ETLA procedures will be performed under general anesthesia. Each procedure will be limited to treatment in a single lung, with either unilateral or bilateral treatment over the two procedures.

Первичные конечные точки

• Percent of procedures where the device operated as intended [Срок оценки: Through completion of the second procedure, approximately 13 weeks]
• Incidence of serious adverse events (SAE) [Срок оценки: 6 months]

Вторичные конечные точки (7)

• Incidence of adverse events [Срок оценки: 9 months]
• Incidence of serious adverse events (SAE) [Срок оценки: 9 months]
• Residual volume (RV) change [Срок оценки: 3, 6, and 9 months]
• FEV1 change [Срок оценки: 3, 6, and 9 months]
• RV/TLC change [Срок оценки: 3, 6, and 9 months]
• 6MWT change [Срок оценки: 3, 6, and 9 months]
• SGRQ-C change [Срок оценки: 3, 6, and 9 months]

Критерии участия

Критерии включения

• Age ≥ 40 years old
• Diagnosis of COPD with FEV1/FVC less than 0.7 post-bronchodilation
• Post-bronchodilator Forced Expiratory Volume (FEV1) ≥ 20% and ≤ 49% of predicted value
• Total lung capacity (TLC) ≥ 100% predicted
• Residual volume (RV) ≥ 175% predicted
• 6 Minute Walk Distance (6MWD) ≥ 140 meters
• Dyspnea scoring ≥ 1 on the modified Medical Research Council scale (mMRC)
• Blood gas values of PCO2 ≤ 55 mmHg; PO2 ≥ 45 mmHg on room air
• Optimized medical management (consistent with GOLD guidelines) as confirmed by the Investigator
• Non-smoking for 3 months prior to study enrollment, as confirmed by lab testing
• Participant must engages in physical exercise beyond activities of daily living (i.e., a walking program, pulmonary rehabilitation) on n a regular basis for more than 6 weeks prior to enrollment and agree to continue the activity throughout study participation
• Participant must live within approximately 1 hour of the study hospital, or live within 1 hour of adequate regional care, or be willing to remain in the hospital for at least five days post-procedure
• Vaccinated for COVID-19, pneumococcus, and influenza (per European Union and Member State guidelines) or documented clinical intolerance or documented patient refusal
• Cognitively able to provide written informed consent and willing to comply with study requirements
• Severe emphysematous lung subsegments eligible for ETLA treatment

Критерии исключения

• Body mass index (BMI) < 16 kg/m\^2 or ≥ 33 kg/m\^2
• DLCO < 20% predicted
• Chronic bronchitis as defined by cough and sputum production for at least 3 months per year for two consecutive years, in the absence of other conditions that can explain these symptoms
• 75ml or greater sputum production per day most days of the week
• Greater than two hospitalizations for COPD exacerbations and/or pneumonia in the 12 months prior to enrollment
• Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines
• Prior lung volume reduction via endobronchial valves(s), coil(s), vapor and/or polymer. Patients whose valves have been removed > 3 months previously can be treated if a baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation and the reason for valve removal was not for complications e.g., Pneumonia, severe exacerbation, or pneumothorax.
• Pulmonary hypertension
• Alpha-1 antitrypsin deficiency
• Uncontrolled diabetes mellitus
• Prior heart or lung transplant
• Myocardial infarction or stroke within the 12 months of enrollment
• Diagnosis of heart failure
• Heart failure requiring hospitalization, within 6 months prior to enrollment
• History of bleeding disorders or enhanced predisposition to bleeding
• History of severe/massive hemoptysis defined as >200ml of blood loss in < 24 hours
• Unable to discontinue anti-coagulants or platelet inhibitors (acetylsalicylic acid \[ASA\]and non-ASA, including low dose) for at least 7 days prior to each procedure (or as per physician discretion based on the specific agent) and for at least 6 weeks after each procedure
• Daily systemic steroids equivalent to > 15mg prednisolone
• Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue/organ rejection
• Pregnant, lactating, or women of childbearing potential that plan to become pregnant within the study duration
• Currently enrolled in another trial studying an experimental treatment
• Any disease or condition likely to limit survival to less than one year
• Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA
• Any condition that would interfere with evaluation or completion of the study including study assessments and procedures, including bronchoscopy.
• Active aspergillus infection
• Clinically significant bronchiectasis as determined by the Investigator
• Radiological evidence of bronchiectasis in target region(s) and/or cystic radiological bronchiectasis in any region of the lungs
• Clinically significant pulmonary fibrosis
• Lung nodule not proven stable unless proven to have benign pathology
• Large bulla (defined as > 1/3 volume of a lung)
• Prior Lung Volume Reduction Surgery (LVRS), bullectomy, or lobectomy
• The remaining lung tissue NOT targeted for ETLA treatment is too highly diseased
• Active respiratory infection or recent respiratory infection with resolution < 4 weeks prior to screening or procedure
• Recent COPD exacerbation within < 6 weeks prior to screening or procedure

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 4 центра

• Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin — Berlin
• Asklepios Lungenklinik Gauting GmbH — Gauting
• Asklepios Klinik Barmbek — Hamburg
• Thoraxklinik University of Heidelberg — Heidelberg

Австрия · 2 центра

• Universitätsklinikum Allgemeines Krankenhaus Wien — Vienna
• Klinik Floridsdorf — Vienna

Нидерланды · 1 центр

• University Medical Center Groningen — Groningen

Идентификаторы

NCT: NCT06655428 · CSP-12123 · CIV-24-04-046660

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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