Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Primary Soft Tissue Lesions of the Lung
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-006626
NCT ID: NCT03603652
Sponsor Protocol Number: NEU_2017_06
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Signed informed consent.
- Patients ≥ 18 years old.
- Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
- Willing to fulfill all follow-up visit requirements.
- Medically inoperable primary soft tissue lesion of the lung or patient election not to have surgery. (Medically inoperable is defined per the following indicators: post op predictive FEV1 (forced expiratory volume in 1 second) < 40%; DLCO (diffusing capacity of the lung for carbon monoxide) < 40%; hypoxemia or hypercapnia diabetes with end-organ damage; or severe cerebral, cardiovascular, peripheral vascular disease, or chronic heart disease).
- One soft tissue lesion ≤ 2 cm in the outer two thirds of the lung and not closer than 1 cm to the pleura.
- Outer two thirds of the lung is defined as peripheral beyond the segmental airway, past the segmental bronchi, such that proximal endobronchial soft tissue lesions are avoided; soft tissue lesions should not be contiguous with the pleura)
- Radiographic resolution of pneumonia.
Exclusion Criteria:
- Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.
- Pregnant or breastfeeding.
- Physical or psychological condition that would impair study participation.
- Patients with uncorrectable coagulography at time of screening.
- Patient with implantable devices, including pacemakers or other electronic implants.
- Prior pneumonectomy or bronchiectasis.
- Severe neuromuscular disease.
- Platelet count ≤ 50,000/mm3.
- ASA (American Society of Anesthesiologists) score of ≥ 4.
- Inability to tolerate anesthesia.
- Expected survival less than 6 months.
- Clinically significant hypertension.
- Chronic ventilator support, which uses bi-level positive airway pressure (PAP).
- Endobronchial soft tissue lesions proximal to the segmental airways.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Janani Reisenauer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available