The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Bronchoscopic Microwave Ablation of Lung Tissue
Official Title: Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue
Study ID: NCT05786625
Brief Summary: 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.
Detailed Description: This is a post-market, prospective, single-arm, multicentre, non-randomized, observational study which will enrol up to 32 subjects in total (plus replacements) at up to 6 clinical investigation sites in Europe and potentially 1 site in the US. Prospective patients must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. 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. Patients who meet the eligibility requirements will 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Royal Brompton and Harefield NHS Foundation Trust, London, , United Kingdom
Name: Pallav L Shah, MD
Affiliation: Royal Brompton & Harefield NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR