Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

NCT06689488 | Recruiting DMC

• 1 other identifier: PD-GTD-AB1-003
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation prior to surgery.

Conditions

Lung Cancer

Keywords

Bronchoscopy; Ablation; Microwave; Lung cancer

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoint

  Stage A - Ablate (Day 0) \& Resect (Day 0) Identification of serious device-related intra-procedural adverse events related to the use of the AB1 system on Day 0 prior to surgical resection defined by the initial skin incision (number and nature of serious adverse events, both device and procedure related, will be identified).

  Day 0, day of ablation procedure up to initiation of surgical resection procedure.

• Primary Safety Endpoint

  Stage B - Ablate (Day 0) \& Resect (Resection Day 7-21) Identification of serious device-related adverse events related to the use of the AB1 system from day 0 up to initiation of surgical resection procedure (number and nature of serious adverse events, both device and procedure related, will be identified).

  Day 7-21, post ablation procedure up to initiation of surgical resection procedure.

• Primary Performance (Efficacy) Endpoint

  Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of 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 1 week post ablation procedure.

Secondary Outcomes (4)

• Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion

  Up to 1 week post ablation procedure.

• Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT

  Up to 1 week post ablation procedure.

• Secondary Performance (Efficacy) Endpoints - Procedural Time

  Up to 1 week post ablation procedure.

• Secondary Performance (Efficacy) Endpoints - Assessment of ease of system use (clinician questionnaires)

  Up to 1 week 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 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 sites.

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):
• ≤ 30 mm in the largest dimension of the pulmonary window for Stage A.
• ≤ 20 mm in the largest dimension of the pulmonary window for Stage B.
• Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
• Greater than 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 bleeding diathesis, uncorrectable coagulopathy, or platelet count ≤ 100 x 10\^9/L.
• Have an implantable device, including pacemakers or other electronic implants.
• Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \>50mmHg).
• Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can´t be stopped or temporarily withheld.
• Subject had a prior pneumonectomy.
• Diagnosis of Small Cell Lung Cancer.
• Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
• 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 (1)

Amsterdam University Medical Centres, Location AMC, Meibergdreef 9

Amsterdam, The Netherlands, 1105 AZ, Netherlands

RECRUITING

Related Publications (6)

• 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

• 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

• 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

• 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

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

  BACKGROUND

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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT 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

Study Officials

• Jouke T Annema, MD

  Amsterdam University Medical Centres

  PRINCIPAL INVESTIGATOR

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: November 13, 2024
• First Posted: November 14, 2024
• Study Start: June 17, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)