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Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK

Sponsor: Creo Medical Limited

NCT ID: NCT06869122

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ablation (device)
How long the study runs
Study runs about 17 months (dates as stated)
About the drug or intervention
Ablation — device: Bronchoscopy and microwave ablation of the lung tumour prior to surgical resection.
Patient visit burden
Not specified by the sponsor

In plain English

This UK study is looking at a treatment called bronchoscopic microwave ablation for people with lung cancer. It uses heat delivered through a thin tube passed into the lungs to destroy cancer tissue, and is for people whose tumours are confirmed as cancer and who are suitable for surgery. The study is sponsored by Creo Medical Limited.

Who can take part

  • Adults aged 18 or over who have given informed consent
  • Have lung lesion(s) or nodule(s) confirmed as cancer by laboratory testing
  • Have tumour(s) measuring 20 mm or less at their widest point
  • Are considered suitable for surgery to remove the tumour, as decided by a team of specialists
  • Have more than 10 mm of tumour-free lung tissue between the tumour and the outer lining of the lung (pleura) or the split between lobes (fissure)
  • Are fit enough for general anaesthesia (ASA score of 3 or below, or judged fit by the team)
  • Are willing and able to follow the study schedule and requirements

Who may not be able to

  • Tumour is in the 'central zone' of the lung, near major airways, large blood vessels, the heart, food pipe (oesophagus), spinal cord, or certain nerves
  • Are pregnant or breastfeeding
  • Have taken part in another research study of a drug or device in the last 30 days that could interfere with this study
  • Have a health condition that would make taking part unsafe or difficult
  • Are expected to live less than 12 months
  • Have an implanted device, such as a pacemaker or other electronic implant
  • Have known pulmonary hypertension (high blood pressure in the lung arteries)
  • Have previously had a whole lung removed (pneumonectomy)
  • Have small cell lung cancer
  • Have had treatment such as stereotactic body radiotherapy (SBRT) in the same lobe as the target tumour
  • Have had chemotherapy, immunosuppressive treatment, or radiotherapy within 3 months of the planned study procedure

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
18
Started
2025-07-14
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for lung cancer
  • • Clinical study - 18 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with lung cancer

Where?

  • • London - Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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.

Lung Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Patients who:
  • ✓Have signed agreement to take part.
  • ✓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.

Who cannot take part

  • ✗Patients who:
  • ✗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...
  • ✗Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare...
  • ✗Have an expected survival less than 12 months.
See the full criteria
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.

Where Is This Study? (1 UK site)

Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street

London SW3 6NP, United Kingdom

Recruiting
Site contact (verified)
Pallav L ShahPrincipal Investigator

How to Get in Touch

Charlie Campion

Sponsor contact

CONTACT

+44 7939 600137 Charlie.Campion@creomedical.com

Annie Goulding

Sponsor contact

CONTACT

+44 1291 606 005 Annie.Goulding@creomedical.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04