Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The participant may enter the study if ALL of the following apply:

⁃ The patient:

• Has signed the informed consent form

• Are ≥ 18 years old

• Has lung lesion(s)/nodule(s) which are histologically confirmed or highly suspicious for cancer and is a candidate for bronchoscopic microwave ablation (as determined by a multi-disciplinary team (MDT) or tumour board).

• Has a medically inoperable soft tissue lung lesion(s) ≤ 20 mm (suspected or confirmed malignancy), or patient has elected not to have surgery / alternative therapy.

• Patient is a candidate for bronchoscopy under general anaesthesia.

• Subject is willing and able to comply with the study protocol requirements.

• Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Locations
Other Locations
Netherlands
Amsterdam University Medical Centres, Location AMC, Meibergdreef 9
RECRUITING
Amsterdam
United Kingdom
Royal Brompton and Harefield NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Charlie Campion
Charlie.Campion@creomedical.com
+44 7939 600137
Backup
Annie Goulding
Annie.Goulding@creomedical.com
+44 1291 606 005
Time Frame
Start Date: 2023-05-04
Estimated Completion Date: 2026-12
Participants
Target number of participants: 32
Treatments
Microwave ablation
Patients with a single or multiple soft tissue lung lesions that is medically inoperable or for which the patient has declined surgical resection.
Related Therapeutic Areas
Sponsors
Leads: Creo Medical Limited

This content was sourced from clinicaltrials.gov