Bronchoscopic Microwave Ablation of Lung Tissue (AB1MALT)

Creo Medical

Status: Active, not recruiting

Conditions: Lung Cancer

Treatments: Device: Ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT05786625

8-AB1-950

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

35 participants in 1 patient group

Microwave ablation

Description:

Patients with a single or multiple soft tissue lung lesions that is medically inoperable or for which the patient has declined surgical resection.

Treatment:

Device: Ablation