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(for at least one location)
Rochester, MN
Describes the nature of a clinical study. Types include:
Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.
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Closed for enrollment
Jacksonville, FL
The purpose of this study is to assess the safety and efficacy of the Apreo BREATHE System when used to support native airways and regional release of trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to pulmonary hyperinflation despite optimal medical management.
Open for enrollment
The purpose of this story is to identify key radiographic variables that are predictive of symptomatic improvement in those patients undergoing endobronchial valve placement.
Symptomatic management of emphysema continues to be a difficult task by medical therapy alone. Bronchoscopic lung volume reduction (BLVR), utilizing minimal invasive placement of endobronchial valves, has emerged as a new therapeutic option. Early trial data demonstrated statistically and clinically significant improvement in FEV1, 6 minutes walk (6MW) distance, and quality of life. However, following the procedure, there are currently no good early predictors of symptomatic benefit. Often, patients wait several months to know if valve placement was successful. This is not only inconvenient to the patient, but it can also increase adverse effects when a non-functional medical device remains in place.
The purpose of this randomized control study is to evaluate the feasibility of using a miniature (1.1 mm) cryoprobe to perform biopsy of peripheral pulmonary lesions using robotic bronchoscopy.
The purpose of this study is to evaluate if lung ablation improves clinical outcomes for patients deemed to be surgically high-risk.
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.The study includes four arms based on biopsy location and biopsy modality/tool:1. Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)2. Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)3. Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)4. Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)
The study will utilize both retrospective and prospective data collection from patients that already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic biopsies, 3ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria.