NEUWAVE Flexible Probe Study #2

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2022-03-31

Brief Summary

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Patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung will have transbronchial microwave ablation performed using cone beam CT for probe guidance and confirmation.

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Detailed Description

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Adult patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung less than 2cm will undergo transbronchial microwave ablation performed by an interventional pulmonologist or thoracic surgeon using cone beam CT imaging for probe guidance and confirmation on ablation outcome. All treated patients will be followed for one year following the ablation procedure for efficacy and safety.

Conditions

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Cancer of the Lung Lung Cancer Neoplasms, Lung Carcinoma, Non-Small Cell Lung Non-Small Cell Lung Cancer Non-Small Cell Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microwave Ablation

Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon.

Group Type EXPERIMENTAL

Microwave ablation

Intervention Type DEVICE

Microwave ablations will be performed under general anesthesia via a transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound (EBUS) to confirm disease staging.

Interventions

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Microwave ablation

Microwave ablations will be performed under general anesthesia via a transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound (EBUS) to confirm disease staging.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Signed Informed Consent
2. Patients greater or equal to 18 years of age
3. Performance status 0-2 (Eastern Cooperative Oncology Group classification \[ECOG\])
4. Willing to fulfill all follow-up visit requirements
5. Medically inoperable and operable secondary soft tissue lesion(s) of the lung
6. A maximum of two ipsilateral soft tissue lesions less than or equal to 2cm in the outer two-thirds of the lung and not closer than 1cm to the pleura. Lesion size must be measured with at least 2-dimensional imaging.

Exclusion Criteria

1. Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related
2. Pregnant or breastfeeding
3. Physical or psychological condition that would impair study participation
4. Patients with uncorrectable coagulopathy at the time of screening
5. Patient with implantable devices, including pacemakers or other electronic implants
6. Prior pneumonectomy or bronchiectasis
7. Severe neuromuscular disease
8. Patient count less than or equal to 50,000/mm cubed
9. ASA (American Society of Anesthesiologists) score of greater than or equal to 4
10. Inability to tolerate anesthesia
11. Expected survival less than 6 months
12. Clinically significant hypertension
13. Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions (however, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted)
14. Endobronchial soft tissue lesions proximal to the segmental airways
15. Imaging findings of active pulmonary infection
16. The patient was judged unsuitable for study participation by the Investigator for any other reason.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No