Bronchoscopic Microwave Ablation of Lung Tissue (AB1MALT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Ablation

Detailed Description

This is a post-market, prospective, single-arm, multicentre, non-randomized, observational study which will enrol up to 35 subjects in total (plus replacements) at up to 6 clinical investigation sites in Europe and potentially 1 site in the US.

Prospective patients must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. 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. Patients who meet the eligibility requirements will undergo a pre-procedural assessment, a bronchoscopy procedure that includes ablation treatment with MicroBlate™ Flex AB1, a post-procedural assessment and 6 follow-up visits at, 7 days (by phone call or in person), 31-45 days, 3 months, 6 months, 9 months and 12 months.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam University Medical Centres, Location AMC, Meibergdreef 9
• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton and Harefield NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled in the proposed study must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. Patients without a histologically confirmed diagnosis of cancer may be enrolled if a multi-disciplinary board deems that it is highly likely that their lung lesion is a malignancy.

Description

Inclusion Criteria:

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

The patient:

1. Has signed the informed consent form
2. Are ≥ 18 years old
3. 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).
4. 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.
5. Patient is a candidate for bronchoscopy under general anaesthesia.
6. Subject is willing and able to comply with the study protocol requirements.
7. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Exclusion Criteria:

The participant may not be enrolled in the study if ANY of the following apply:

For patients undergoing procedures employing robotic-assisted bronchoscopy:

1. a. Target nodule(s) are within 10mm of the trachea, right and left main bronchus, aorta, central pulmonary arteries, heart, oesophagus, spinal cord, phrenic & laryngeal nerves.

Note: Exclusion Criteria 1a is UK-specific.

For patients undergoing procedures without the use of robotic-assisted bronchoscopy (manual procedures):

1. b. Target nodule(s) are within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord and phrenic and laryngeal nerves), or are <10 mm from the pleura.
2. Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification.
3. Are pregnant or breast feeding, as determined by standard site practices.
4. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
5. Are scheduled for concurrent interventional procedure for the target soft tissue lesion.
6. Have a physical or psychological condition or other factor(s) that would impair study participation, or jeopardise the safety or welfare of the subject.
7. Have an expected survival less than 6 months.
8. Have patients with bleeding diathesis, uncorrectable coagulopathy or platelet count ≤ 100 x 10⁹ /L.
9. Have an implantable devices, including pacemakers or other electronic implants.
10. Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] > 50mmHg).
11. Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which cannot be stopped or temporarily withheld.

12. Any patient with clinically significant interstitial lung disease in the zone of planned ablation.

    Note: Exclusion Criteria 12 is NL-specific.

13. Patient has nodal disease confirmed through invasive or image-based staging. Note: if nodal disease is suspected or detected during the staging procedure conducted prior to use of the investigational device during the study procedure, the subject will be excluded.
14. Subject had a prior pneumonectomy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Ablation; Bronchoscopy and microwave ablation of lung nodule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Performance (Efficacy) Endpoint	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 and confirmed ablation as evidenced by assessment of CT. The criterion for meeting the Performance (efficacy) endpoint excludes study system malfunctions.	Up to day 30 patient visit.
Primary Safety Endpoint	Identification of serious device-related adverse events related to the use of the AB1 system up to 30 days after the ablation procedure (number and nature of serious adverse events, both device- and procedure- related, will be identified) including, but not limited to: Moderate bleeding (intervention required such as use of balloon tamponade or Surgicel) or severe bleeding (prolonged monitoring necessary or fatal bleeding); Pneumothorax; Failure of extubation; ICU admission for respiratory failure within 30 days; Death within 30 days.	Up to 30 days after the ablation procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint	Identification of all device-related, procedure related and other adverse events related to bronchoscopic microwave ablation interventions using the AB1 system.	Up to 12 months post ablation.
Secondary Effectiveness Outcomes - Rate of tumor recurrence	Rate of recurrence at all time points as determined by the multidisciplinary team (MDT) or tumour board.	Up to 12 months
Secondary Effectiveness Outcomes - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C)	Patients will rate their responses from 1 to 4 on a Likert Scale (1 being "not at all" and 4 being "very much").	Up to 12 months
Secondary Effectiveness Outcomes - Patient-reported pain rating on a visual analogue scale	Patients will rate their pain on a visual analogue scale from 0 to 10 (where 0 is no pain and 10 is the most severe pain).	Up to 45 days post-ablation
Secondary Effectiveness Outcomes - Assessment/visualization/quantification of the dimensions of the ablated tissue	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 12 months
Secondary Effectiveness Outcomes - Procedural Time	Procedural time to be captured in the electronic case report form (eCRF).	Up to 1 day post ablation procedure.
Secondary Effectiveness Outcomes - 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 easy" and 7 being "extremely difficult".	Up to 1 day post ablation procedure.
Secondary Effectiveness Outcomes - EQ-5D-5L health-related quality of life questionnaire	Patients complete the 5 level descriptive system relating to 5 dimensions of health and the EQ visual analogue scale from 0 to 100 (where 0 means the worst health you can imagine and 100 means the best health you can imagine).	Up to 12 months

Collaborators and Investigators

• Sponsor: Creo Medical Limited
• Collaborators: Avania
• Investigators: Principal Investigator: Pallav L Shah, MD, Royal Brompton and Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Actual): November 26, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Neoplasms; Bronchoscopy; Ablation; Microwave
• Additional Relevant MeSH Terms: Neoplasms by Site; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 8-AB1-950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Single site

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