Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates (AB1MALTISC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Ablation

Detailed Description

This is a post-market, prospective, single-arm, multicentre, open-label, non-randomised study which will enrol up to 30 subjects in total (plus replacements if required due to drop out).

Prospective patients must have a histopathological-confirmed malignant lung lesion and be candidates for surgical resection. 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.

The study consists of two (2) stages (Stage A and Stage B). Stage A consists of the ablation and surgical resection being performed concurrently on Day 0 within a single procedure. Stage B consists of the ablation and the surgical resection being performed in separate procedures. The surgical resection will occur between Day 7 and Day 21, post-ablation, inclusive of those days. The aim is to follow local guidelines for treatment of lung cancer.

Patients undergoing Stage A will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).

Patients undergoing Stage B will have evaluations at follow-up visits conducted at 7 (+/-3) days (via phone call) post ablation and prior to the surgical resection procedure. Stage B patients will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Annie Goulding; Phone Number: +44 1291 606 005; Email: Annie.Goulding@creomedical.com
• Study Contact Backup: Name: Charlie Campion; Phone Number: +44 7939 600137; Email: Charlie.Campion@creomedical.com

Study Locations

• Netherlands
  • The Netherlands
    • Amsterdam, The Netherlands, Netherlands, 1105 AZ
      • Recruiting
      • Amsterdam University Medical Centres, Location AMC, Meibergdreef 9
      • Contact: Saskia van Heumen, Technical Physician; Phone Number: +31 20 566 3852; Email: s.vanheumen@amsterdamumc.nl
      • Principal Investigator: Jouke T Annema, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

General population going through lung cancer screening at investigative sites.

Description

Inclusion Criteria:

Patients who:

1. Have signed informed consent.
2. Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
3. Are ≥ 18 years old.
4. Have lung lesion(s)/nodule(s) which are histopathological-confirmed as cancer.

5. 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.
6. Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
7. Greater than 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
8. Subject is willing and able to comply with the study protocol requirements.
9. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Exclusion Criteria:

Patients who:

1. 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).
2. Are pregnant or breast feeding, as determined by standard site practices.
3. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
4. Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
5. Have an expected survival less than 12 months.
6. Have bleeding diathesis, uncorrectable coagulopathy, or platelet count ≤ 100 x 10^9/L.
7. Have an implantable device, including pacemakers or other electronic implants.
8. Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] >50mmHg).
9. Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can´t be stopped or temporarily withheld.
10. Subject had a prior pneumonectomy.
11. Diagnosis of Small Cell Lung Cancer.
12. Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
13. Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
14. Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Microwave ablation; Patients with a malignant lung nodule who are candidates for surgical resection.	Device: Ablation; Bronchoscopy and microwave ablation prior to surgical resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion	Dimensions of the ablated tissue to confirm, correct or add to the IFU-reported relationship between AB1 ablation time and dimensions and volume of the ablated tissue, per pre-specified target.	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	Dimensions of the ablated tissue as evidenced on the post ablation CT.	Up to 1 week post ablation procedure.
Secondary Performance (Efficacy) Endpoints - Procedural Time	Procedural time to be captured in the electronic case report form (eCRF).	Up to 1 week post ablation procedure.
Secondary Performance (Efficacy) Endpoints - Assessment of ease of system use (clinician questionnaires)	Questionnaires to be completed by clinicians, rating their responses on a Likert scale of 1 to 7, with 1 being "extremely clear/easy" and 7 being "extremely difficult".	Up to 1 week post ablation procedure.

Collaborators and Investigators

• Sponsor: Creo Medical Limited
• Investigators: Principal Investigator: Jouke T Annema, MD, Amsterdam University Medical Centres

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• SABR UK Consortium. "Stereotactic Ablative Body Radiation Therapy (SABR): A Resource." Version 6.1. January 2019
• Chang et al The Lancet Oncology 2015 Vol 16, Issue 6, 630 - 637

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Bronchoscopy; Lung cancer; Ablation; Microwave
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: PD-GTD-AB1-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Summary aggregate information will be published in a PRJA at the conclusion of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No