The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
Official Title: A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Medically Inoperable Primary Soft Tissue Lesions of the Lung: An Initial Experience
Study ID: NCT03603652
Brief Summary: Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.
Detailed Description: Patients with medically inoperable primary soft tissue lesion of the lung (lesions less than or equal to 2cm and located in the outer two-thirds of the lung and not closer than 1cm to the pleura) will have transbronchial microwave ablation performed using CT imaging. All ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety with specific follow-up visits at 30 days, 6 months, and 12 months post-ablation. A user experience questionnaire is completed by the treating physician to better understand the ease of the procedure.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
Mayo Clinic, Rochester, Minnesota, United States
New York Presbyterian-Weill Cornell Medicine, New York, New York, United States
FirstHealth Moore Regional Hospital, Pinehurst, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Name: Thomas Gildea, MD
Affiliation: The Cleveland Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Pritchett, MD
Affiliation: FirstHealth Moore Regional Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Janani Reisenauer, MD
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
Name: Bradley Pua, MD
Affiliation: Cornell
Role: PRINCIPAL_INVESTIGATOR
Name: Jae Kim, MD
Affiliation: City of Hope Medical Center
Role: PRINCIPAL_INVESTIGATOR