Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-14

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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, we 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 a single site in the UK, and will involve up to 18 participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates

NCT06689488

Lung Cancer

RECRUITING

Bronchoscopic Microwave Ablation of Lung Tissue

NCT05786625

Lung Cancer

ACTIVE_NOT_RECRUITING

NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung

NCT03603652

Cancer of Lung Cancer of the Lung Lung Cancer +4 more

TERMINATED NA

Electrocautery Ablation for the Prevention of Lung Cancer

NCT03870152

Lung Cancer Squamous Cell

TERMINATED PHASE2/PHASE3

Efficacy and Safety of Cryoablation with Robotic Bronchoscopy System in Patients with Lung Cancer

NCT06832956

Lung Cancer Patients

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participation (approximately 2 months) in this study, will include a screening visit, a bronchoscopy procedure that includes the microwave ablation treatment, and the planned surgical removal of the lung tumour 7 to 21 days after the ablation.

There are 2 follow-up visits, one at 7 days after the ablation treatment, the second just before the planned surgical procedure. After surgery, patients will be monitored according to the hospital's routine clinical practice. Participation in the research study ends once the patient is discharged from hospital.

Participation in this study has the potential to provide the following benefits for other people who have the same medical condition:

* The option of choosing microwave ablation as an alternative treatment for lung tumours and avoiding a major surgical procedure.
* Shorter patient recovery times.
* Reduced incidence of complications.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Microwave ablation

Patients with a malignant lung nodule who are candidates for surgical resection.

Ablation

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ablation

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients who:

1. Have signed informed consent.
2. Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
3. Are ≥ 18 years old.
4. Have lung lesion(s)/nodule(s) which are histopathological confirmed as cancer.
5. Have soft tissue lung lesion(s):

* ≤ 20 mm in the largest dimension of the pulmonary window
6. Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
7. \> 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
8. Subject is willing and able to comply with the study protocol requirements.
9. Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Exclusion Criteria

Patients who:

1. 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).
2. Are pregnant or breast feeding, as determined by standard site practices.
3. Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
4. Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
5. Have an expected survival less than 12 months.
6. Have an implantable device, including pacemakers or other electronic implants.
7. Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \>50mmHg).
8. Subject had a prior pneumonectomy.
9. Diagnosis of Small Cell Lung Cancer.
10. Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
11. Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No