Bronchoscopic Microwave Ablation of Lung Tissue

NCT05786625 | Active Not Recruiting DMC

• 1 other identifier: 8-AB1-950
• Study Type: observational
• Target: 35
• Locations: 2 countries
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

Neoplasms; Bronchoscopy; Ablation; Microwave

Outcome Measures

Primary Outcomes (2)

• Primary Performance (Efficacy) Endpoint

  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.

  Up to day 30 patient visit.

• Primary Safety Endpoint

  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.

  Up to 30 days after the ablation procedure.

Secondary Outcomes (8)

• Secondary Safety Endpoint

  Up to 12 months post ablation.

• Secondary Effectiveness Outcomes - Rate of tumor recurrence

  Up to 12 months

• Secondary Effectiveness Outcomes - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C)

  Up to 12 months

• Secondary Effectiveness Outcomes - EQ-5D-5L health-related quality of life questionnaire

  Up to 12 months

• Secondary Effectiveness Outcomes - Patient-reported pain rating on a visual analogue scale

  Up to 45 days post-ablation

Study Arms (1)

Microwave ablation

Patients with a single or multiple soft tissue lung lesions that is medically inoperable or for which the patient has declined surgical resection.

Device: Ablation

Interventions

Ablation DEVICE

Bronchoscopy and microwave ablation of lung nodule

Microwave ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled in the proposed study must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. Patients without a histologically confirmed diagnosis of cancer may be enrolled if a multi-disciplinary board deems that it is highly likely that their lung lesion is a malignancy.

You may qualify if:

• The participant may enter the study if ALL of the following apply:
• The patient:
• Has signed the informed consent form
• Are ≥ 18 years old
• 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).
• 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.
• Patient is a candidate for bronchoscopy under general anaesthesia.
• Subject is willing and able to comply with the study protocol requirements.
• Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

You may not qualify if:

• The participant may not be enrolled in the study if ANY of the following apply:
• For patients undergoing procedures employing robotic-assisted bronchoscopy:
• \. 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.
• For patients undergoing procedures without the use of robotic-assisted bronchoscopy (manual procedures):
• b. Target nodule(s) are within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord and phrenic and laryngeal nerves), or are \<10 mm from the pleura.
• Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification.
• 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.
• Are scheduled for concurrent interventional procedure for the target soft tissue lesion.
• Have a physical or psychological condition or other factor(s) that would impair study participation, or jeopardise the safety or welfare of the subject.
• Have an expected survival less than 6 months.
• Have patients with bleeding diathesis, uncorrectable coagulopathy or platelet count ≤ 100 x 10⁹ /L.
• Have an implantable devices, including pacemakers or other electronic implants.
• Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \> 50mmHg).
• Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which cannot be stopped or temporarily withheld.

Sponsors & Collaborators

• Creo Medical Limited: lead

Study Sites (2)

Amsterdam University Medical Centres, Location AMC, Meibergdreef 9

Amsterdam, 1105 AZ, Netherlands

Location

Royal Brompton and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum and plasma

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pallav L Shah, MD

  Royal Brompton and Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 27, 2023
• Study Start: May 4, 2023
• Primary Completion: November 26, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

NL (1); GB (1)