Partners for a clinical investigation of bronchoscopic oxygen delivery in chronic respiratory disease

We are building a consortium for the Horizon Europe topic HORIZON-HLTH-2027-02-DISEASE-01-two-stage, “Innovative healthcare interventions for non-communicable diseases”, with a focus on chronic respiratory diseases. The first-stage proposal is due on 17 February 2027, and invited applicants submit the full proposal by 16 September 2027.

Oxygen desaturation is the most frequent complication of sedated flexible bronchoscopy, and patients with COPD, asthma or interstitial lung disease make up a large share of those undergoing it. Oxygen given through the working channel occupies it, and high-flow nasal oxygen requires additional equipment. Our sterile disposable coaxial oxygen catheter slides over the existing bronchoscope shaft and is designed to deliver oxygen through the annular gap below the glottis, keeping the working channel free and requiring no additional capital equipment or change in workflow. Oxygen delivery below the glottis through the bronchoscope has been studied in randomised trials in fibreoptic intubation, and our catheter refines this principle.

We propose a rigorous early-stage clinical investigation of the catheter in patients with chronic respiratory diseases undergoing sedated bronchoscopy, with comorbidities addressed in the trial design, patients and bronchoscopy teams involved in shaping the intervention and a health-economic assessment based on real-world data from procedural care.

Lungstream takes responsibility for the investigational device. We bring the design specification, simulation and bench testing, a preclinical in vivo study in preparation and design verification including biocompatibility, sterilisation and risk management to ISO 14971, and we supply sterile investigational devices with labelling, instructions for use and training for site staff. We also contribute the investigator’s brochure and the device documentation under Annex XV of the EU MDR, device-specific input to the clinical investigation plan under ISO 14155 and to the preliminary consultations with ethics committees and competent authorities. Usability engineering to IEC 62366-1, a health-economic model of sedation-related events and our clinical network for site selection and recruitment planning complete our contribution.

We are looking for an experienced coordinator, ideally a university hospital or academic centre with a track record in multicentre clinical research, and for clinical sites in EU Member States and Associated Countries with high volumes of sedated bronchoscopy and experience in clinical investigations of medical devices. We also seek a clinical trial unit or research infrastructure for methodology, statistics and data management, a partner in health economics and real-world data, social sciences and humanities expertise in patient experience and implementation, a digital health partner for peri-procedural monitoring and data capture, and patient organisations in chronic respiratory disease.

If your organisation would like to take on one of these roles, we would be glad to hear from you and to share more detail in a call well ahead of the first-stage deadline.