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Research

Active Studies

  • SNIPE : First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System

    This is a prospective, open label, multi center, single arm, first in human study to assess the safety and initial performance of EAS1 system for Irreversible Electroporation (IRE) ablation of lung cancer in subjects eligible for tumour resection. Up to 15 subjects (plus replacements) are enrolled in the study.

    Subjects undergo ablation of the lung tumour via Irreversible Electroporation (IRE) method performed bronchoscopically, followed by resection of the tumour up to 19 days after the ablation.

    Study Details | Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema | ClinicalTrials.gov

  • AB1MALTISC-UK : Bronchoscopic microwave ablation of lung tumours in surgical candidates

    Status: Recruiting

    This study involves the use of the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy. In this study, we are investigating whether the ablation instrument can be used effectively to treat lung tumours or tumours that have spread to the lungs. If successful, using this technology may mean future patients may not need to undergo surgical removal of these types of lung tumours. Up to 18 subjects (plus replacements) are enrolled in the study. All participants will undergo the microwave ablation procedure, followed by a surgical resection of the tumour up to 21 days after ablation.

    Link: https://clinicaltrials.gov/study/NCT06869122?id=nct06869122&rank=1

  • AB1MALT : Bronchoscopic microwave ablation of Lung Tumours

    Status: Recruiting

    This is a post-market, prospective, single-arm, multicentre, non-randomized study which enrolling up to 32 subjects in total (plus replacements). The primary purpose of this study is to evaluate the safety and feasibility of the Creo Medical MicroBlate™ Flex AB1 instrument used with the AB1 electrosurgical system in patients undergoing bronchoscopic microwave ablation of peripheral lung nodules. Subjects include patients with a suitable soft tissue lung lesion, who are not surgical candidates or decline surgery. Subjects who meet the eligibility requirements undergo a pre-procedural assessment, a bronchoscopy procedure that includes ablation treatment with MicroBlate™ Flex AB1, a post-procedural assessment and 6 follow-up visits at, 7 days (by phone call or in person), 31-45 days, 3 months, 6 months, 9 months and 12 months.

    Link: https://clinicaltrials.gov/study/NCT05786625

  • Ryme Medical Targeted Lung Denervation Pilot study

    Status: Active, not recruiting.

    The Ryme Medical Lung Denervation System is a new, experimental device that consists of a balloon catheter to freeze the overactive nerves in COPD to improve symptoms of COPD. This first in human study will include up to 40 patients in 4 sites in Europe and the UK, with a 12-month post procedure follow up for patients.

    Link: https://clinicaltrials.gov/study/NCT05967091

  • BREATHE-2 : Bronchoscopic Release of Air Trapped in Hyperinflated Emphysematous Lung

    Status: Active, not recruiting.

    Emphysema is a lung disease that results from damage to the walls of the alveoli of the lungs. A blockage (obstruction) may develop, which traps air inside the lungs. The Apreo Implant is designed to open lung airways, allowing trapped air to escape, thereby reducing hyperinflation of the lungs. This multi-centre study is being carried out to assess the safety, feasibility and preliminary efficacy of the Apreo Implant for severe emphysema in up to 60 participants.

    Link: https://clinicaltrials.gov/study/NCT05949645

  • Resolve : Clinical Study of the RheOx Bronchial Rheoplasty System in Treating the Symptoms of Chronic Bronchitis

    Status: Active, not recruiting.

    Bronchial Rheoplasty (investigational treatment) is designed to remove the tissue layers of the airway where the abnormal mucus cells are located. It is expected the airway tissue will heal more normally after treatment, and thereby reduce the symptoms associated with chronic bronchitis, such as cough and phlegm. The purpose of the study is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 270 patients will be randomised in multiple centres including in Europe, United States and Canada.  study centres and up to 10 centres outside the US (Canada and Europe) and they will be followed up for 2 years.

    Link: https://clinicaltrials.gov/study/NCT04677465

  • SPRAY-CB : RejuvenAir® System Trial for COPD With Chronic Bronchitis

    Status: Active, not recruiting.

    The RejuvenAir® System is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area to ablate tissue in the airways that causes cough and sputum production and allow regrowth of healthier epithelial cells to reduce the symptoms associated with chronic bronchitis. This is study designed to demonstrate the safety and effectiveness of the RejuvenAir® System for the treatment of adults with a diagnosis of chronic bronchitis and COPD comparing treatment to Sham Control Arm in a 2:1 randomised control trial.  Those randomized to the Sham Control Arm will have the option to cross over to the treatment arm after the 12 month follow up visit. Patients in this study will be followed for 24 months.

    Link: https://clinicaltrials.gov/study/NCT03893370

Completed Studies

  • Step-Up Trial

    This therapy is based on thermal ablation of damaged lung with steam vapour. This in turn leads to an inflammatory reaction and fibrosis in a portion of the lung inducing lung volume reduction. Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Recruitment to open at the Royal Brompton Hospital in the near future.

  • Renew Study

    This pivotal study is currently recruiting at the Royal Brompton Hospital (contact Dr Pallav Shah at p.shah@rbht.nhs.uk. Patients are randomised to treatment with lung volume reduction coils or control and followed over one year. The coils are made from nitinol and restoring the tension in the lung. The coils are placed minimally invasively by bronchoscopy under x-ray guidance.

  • Reset Study

    LUNG VOLUME REDUCTION COILS (LVRC’S)
    Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial.
    The Reset study assessed the clinical benefits and safety of lung volume reduction coils (LVRCs) for the treatment of patients with severe emphysema with hyperinflation.

  • EASE trial

    EXHALE STENTS: Airway Bypass Procedure

    The aim of the EASE (Exhale airway stents for emphysema) trial was to evaluate safety and efficacy of airway bypass in people with severe homogeneous emphysema.