Clinical trial NCT05786625: Bronchoscopic Microwave Ablation of Lung Tissue
Official title: Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Neoplasms
Bronchoscopy
Ablation
Microwave
Lead sponsor: Creo Medical Limited
Sponsor class: INDUSTRY
First posted: 2023-03-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

Detailed description: This is a post-market, prospective, single-arm, multicentre, non-randomized, observational study which will enrol up to 32 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.

Eligibility criteria: 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:

1. 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.
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.

Primary outcomes:
measure: Primary Performance (Efficacy) Endpoint
timeFrame: Up to day 30 patient visit.
measure: Primary Safety Endpoint
timeFrame: Up to 30 days after the ablation procedure.
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: Up to 12 months post ablation.
measure: Secondary Effectiveness Outcomes - Rate of tumor recurrence
timeFrame: Up to 12 months
measure: Secondary Effectiveness Outcomes - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C)
timeFrame: Up to 12 months
measure: Secondary Effectiveness Outcomes - EQ-5D-5L health-related quality of life questionnaire
timeFrame: Up to 12 months
measure: Secondary Effectiveness Outcomes - Patient-reported pain rating on a visual analogue scale
timeFrame: Up to 45 days post-ablation
measure: Secondary Effectiveness Outcomes - Assessment/visualization/quantification of the dimensions of the ablated tissue
timeFrame: Up to 12 months
measure: Secondary Effectiveness Outcomes - Procedural Time
timeFrame: Up to 1 day post ablation procedure.
measure: Secondary Effectiveness Outcomes - Assessment of ease of system use (clinician questionnaires)
timeFrame: Up to 1 day post ablation procedure.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centres, Location AMC, Meibergdreef 9
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundation Trust
name: Pallav L Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: