Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK

NCT06869122 | Recruiting DMC

• 1 other identifier: PD-GTD-AB1UK-003
• Study Type: observational
• Target: 18
• Locations: 2 countries
• Sites: 2

Brief 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, the investigators 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 sites in the UK and Italy, and will involve up to 18 participants.

Conditions

Lung Cancer

Keywords

Bronchoscopy; Ablation; Microwave; Lung cancer

Outcome Measures

Primary Outcomes (2)

• Safety of the MicroBlate Flex AB1 system in lung tumour ablation

  Identification of serious device-related adverse events associated with the delivery of microwave energy by the AB1 system from ablation (Day 0) up to the first surgical incision for the resection (Day 7-21)

  Up to 21 days after the ablation procedure

• Technical Success and Performance of the AB1 instrument

  Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of the scheduled microwave energy to the target tissue (per pre-specified target) and confirmed ablation as evidenced by macroscopic assessment post-surgical resection of the ablated lesion

  Up to 28 days post ablation procedure

Secondary Outcomes (4)

• Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion

  Up to 1 week post surgical resection procedure

• Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT

  Up to 1 week post ablation procedure

• Procedural Time

  Up to 1 week post ablation procedure

• Assessment of ease of system use (Clinician Questionnaires)

  Up to 1 week post ablation procedure

Other Outcomes (1)

• Assessment of immunological response following microwave ablation procedure

  Up to 28 days post ablation procedure

Study Arms (1)

Microwave ablation

Patients with a malignant lung nodule who are candidates for surgical resection.

Device: Ablation

Interventions

Ablation DEVICE

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

Microwave ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population going through lung cancer screening at investigative site.

You may qualify if:

• Patients who:
• Have signed informed consent.
• Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
• Are ≥ 18 years old.
• Have lung lesion(s)/nodule(s) which are histopathological confirmed as cancer.
• Have soft tissue lung lesion(s):
• ≤ 20 mm in the largest dimension of the pulmonary window
• Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
• \> 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
• 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.

You may not qualify if:

• Patients who:
• Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic \& laryngeal nerves).
• Are pregnant or breast feeding, as determined by standard site practices.
• Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
• Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
• Have an expected survival less than 12 months.
• Have an implantable device, including pacemakers or other electronic implants.
• Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \>50mmHg).
• Subject had a prior pneumonectomy.
• Diagnosis of Small Cell Lung Cancer.
• Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
• Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.

Sponsors & Collaborators

• Creo Medical Limited: lead

Study Sites (2)

Istituto Europeo di Oncologia (IEO), Via Ripamonti 435

Milan, 20141, Italy

NOT YET RECRUITING

Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street

London, UK, SW3 6NP, United Kingdom

RECRUITING

Related Publications (6)

• Chang et al The Lancet Oncology 2015 Vol 16, Issue 6, 630 - 637

  BACKGROUND

• SABR UK Consortium. "Stereotactic Ablative Body Radiation Therapy (SABR): A Resource." Version 6.1. January 2019.

  BACKGROUND

• Chen H, Senan S, Nossent EJ, Boldt RG, Warner A, Palma DA, Louie AV. Treatment-Related Toxicity in Patients With Early-Stage Non-Small Cell Lung Cancer and Coexisting Interstitial Lung Disease: A Systematic Review. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):622-631. doi: 10.1016/j.ijrobp.2017.03.010. Epub 2017 Mar 15.

  PMID: 28581404 BACKGROUND

• Boffa DJ, Allen MS, Grab JD, Gaissert HA, Harpole DH, Wright CD. Data from The Society of Thoracic Surgeons General Thoracic Surgery database: the surgical management of primary lung tumors. J Thorac Cardiovasc Surg. 2008 Feb;135(2):247-54. doi: 10.1016/j.jtcvs.2007.07.060. Epub 2007 Dec 21.

  PMID: 18242243 BACKGROUND

• Licker MJ, Widikker I, Robert J, Frey JG, Spiliopoulos A, Ellenberger C, Schweizer A, Tschopp JM. Operative mortality and respiratory complications after lung resection for cancer: impact of chronic obstructive pulmonary disease and time trends. Ann Thorac Surg. 2006 May;81(5):1830-7. doi: 10.1016/j.athoracsur.2005.11.048.

  PMID: 16631680 BACKGROUND

• Covey AM, Gandhi R, Brody LA, Getrajdman G, Thaler HT, Brown KT. Factors associated with pneumothorax and pneumothorax requiring treatment after percutaneous lung biopsy in 443 consecutive patients. J Vasc Interv Radiol. 2004 May;15(5):479-83. doi: 10.1097/01.rvi.0000124951.24134.50.

  PMID: 15126658 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Resected lung tissue and blood samples.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Charlie Campion

CONTACT

+44 7939 600137; Charlie.Campion@creomedical.com

Annie Goulding

CONTACT

+44 1291 606 005; Annie.Goulding@creomedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); IT (1)