NEUWAVE Flexible Probe Study #2



Status:Not yet recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:July 1, 2019
End Date:May 31, 2021
Contact:Bertha Fearon
Email:bfearon1@its.jnj.com
Phone:908-524-3749

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A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung

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.

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.

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.
We found this trial at
5
sites
Duarte, California 91010
Principal Investigator: Jae Kim
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Duarte, CA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Thomas Gildea
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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425 East 61st Street
New York, New York 10065
Principal Investigator: Bradley Pua
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New York, NY
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Pinehurst, North Carolina 28374
Principal Investigator: Michael Pritchett
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Pinehurst, NC
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Rochester, Minnesota 55905
Principal Investigator: Janani Reisenauer
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Rochester, MN
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