Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates
ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCreo Medical Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
General population going through lung cancer screening at investigative sites.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ablation
DeviceBronchoscopy and microwave ablation prior to surgical resection.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Microwave ablation1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Day 0, day of ablation procedure up to initiation of surgical resection procedure.2
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).
Time frame
Day 7-21, post ablation procedure up to initiation of surgical resection procedure.3
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.
Time frame
Up to 1 week post ablation procedure.Secondary outcomes
1
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.
Time frame
Up to 1 week post ablation procedure.2
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.
Time frame
Up to 1 week post ablation procedure.3
Secondary Performance (Efficacy) Endpoints - Procedural Time
Procedural time to be captured in the electronic case report form (eCRF).
Time frame
Up to 1 week post ablation procedure.4
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".
Time frame
Up to 1 week post ablation procedure.Sponsors and contacts
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Source ClinicalTrials.gov