Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK

ConditionLung Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCreo Medical Limited

About this trial

This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). In this study, the investigators are investigating whether the ablation instrument can be used effectively to treat lung tumours or tumours that have spread to the lungs. If successful, using this technology may mean future patients may not need to undergo surgical removal of these types of lung tumours.

The aim of this study is to evaluate the safety and performance of the MicroBlate Flex instrument in treating individuals with cancerous lung tumours that are due to be removed by surgery. All participants in the study will undergo the microwave ablation procedure, which is a separate and additional procedure to their surgical procedure.

The study, funded by Creo Medical, will be conducted at sites in the UK and Italy, and will involve up to 18 participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 site.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Ablation
Device
Bronchoscopy and microwave ablation of the lung tumour prior to surgical resection.

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: Microwave ablation1 intervention

Trial outcomes

Primary outcomes

Safety of the MicroBlate Flex AB1 system in lung tumour ablation

Identification of serious device-related adverse events associated with the delivery of microwave energy by the AB1 system from ablation (Day 0) up to the first surgical incision for the resection (Day 7-21)

Time frame

Up to 21 days after the ablation procedure

Technical Success and Performance of the AB1 instrument

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 (per pre-specified target) and confirmed ablation as evidenced by macroscopic assessment post-surgical resection of the ablated lesion

Time frame

Up to 28 days post ablation procedure

Secondary outcomes

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 surgical resection procedure

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

Procedural Time

Procedural time to be captured in the electronic case report form

Time frame

Up to 1 week post ablation procedure

Assessment of ease of system use (Clinician Questionnaires)

Questionnaires to be completed by clinicians following each procedure, 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