Lung Cancer
Conditions
Keywords
Neoplasms, Bronchoscopy, Ablation, Microwave
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 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.
Interventions
DEVICEAblation
Bronchoscopy and microwave ablation of lung nodule
Sponsors
Creo Medical Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Performance (Efficacy) Endpoint | Up to day 30 patient visit. | 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. |
| Primary Safety Endpoint | Up to 30 days after the ablation procedure. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoint | Up to 12 months post ablation. | Identification of all device-related, procedure related and other adverse events related to bronchoscopic microwave ablation interventions using the AB1 system. |
| Secondary Effectiveness Outcomes - Rate of tumor recurrence | Up to 12 months | Rate of recurrence at all time points as determined by the multidisciplinary team (MDT) or tumour board. |
| Secondary Effectiveness Outcomes - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C) | Up to 12 months | Patients will rate their responses from 1 to 4 on a Likert Scale (1 being "not at all" and 4 being "very much"). |
| Secondary Effectiveness Outcomes - EQ-5D-5L health-related quality of life questionnaire | Up to 12 months | 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). |
| Secondary Effectiveness Outcomes - Patient-reported pain rating on a visual analogue scale | Up to 45 days post-ablation | 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). |
| Secondary Effectiveness Outcomes - Assessment/visualization/quantification of the dimensions of the ablated tissue | Up to 12 months | 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. |
| Secondary Effectiveness Outcomes - Procedural Time | Up to 1 day post ablation procedure. | Procedural time to be captured in the electronic case report form (eCRF). |
| Secondary Effectiveness Outcomes - Assessment of ease of system use (clinician questionnaires) | Up to 1 day post ablation procedure. | 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". |
Countries
Netherlands, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORPallav L Shah, MD
Royal Brompton and Harefield NHS Foundation Trust
Outcome results
None listed