Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06869122

Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
18 (estimated)
Sponsor
Creo Medical Limited · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). 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. The aim of this study is to evaluate the safety and performance of the MicroBlate Flex instrument in treating individuals with cancerous lung tumours that are due to be removed by surgery. All participants in the study will undergo the microwave ablation procedure, which is a separate and additional procedure to their surgical procedure. The study, funded by Creo Medical, will be conducted at a single site in the UK, and will involve up to 18 participants.

Detailed description

Participation (approximately 2 months) in this study, will include a screening visit, a bronchoscopy procedure that includes the microwave ablation treatment, and the planned surgical removal of the lung tumour 7 to 21 days after the ablation. There are 2 follow-up visits, one at 7 days after the ablation treatment, the second just before the planned surgical procedure. After surgery, patients will be monitored according to the hospital's routine clinical practice. Participation in the research study ends once the patient is discharged from hospital. Participation in this study has the potential to provide the following benefits for other people who have the same medical condition: * The option of choosing microwave ablation as an alternative treatment for lung tumours and avoiding a major surgical procedure. * Shorter patient recovery times. * Reduced incidence of complications.

Conditions

Interventions

TypeNameDescription
DEVICEAblationBronchoscopy and microwave ablation of the lung tumour prior to surgical resection.

Timeline

Start date
2025-07-14
Primary completion
2026-08-01
Completion
2026-09-01
First posted
2025-03-11
Last updated
2025-09-24

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT06869122. Inclusion in this directory is not an endorsement.