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Clinical Studies
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A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
Rochester, Minn.
The purpose of this registry is to evaluate procedure characteristics and short and long-term patient outcomes following shape-sensing robotic-assisted bronchoscopy (ssRAB) utilizing the Ion Endoluminal System for lung lesion localization or biopsy.
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A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of VGT-309, a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Lung Cancer Surgery
Rochester, Minn.
The purpose of this study is to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.
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AFFINITY: A Clinical Study of Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer (AFFINIY)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this early feasibility study (EFS) is to evaluate the safety of delivering Aliya pulsed electric fields ablation in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
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ALgorithms Adapted from Remote Monitoring (ALARM) (ALARM)
Rochester, Minn.
The purpose of this study is to determine, based upon baseline measurements, intra-operative hemodynamic data, and a short course of post-operative monitoring, how a patient responds to the stress of surgery and at what point they return to normal baseline values.
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Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care
(INTERCEPTioN for Suspected Lung Cancer) (INTERCEPTioN)
Rochester, Minn.
The purpose of this study is to determine if robotic biopsies provide sufficient material for whole genomics and transcriptomics, transcriptome anomalies are confined to tumor cells as opposed to background lung parenchyma, and whole genomics may provide further pathologic insight in cases where de novo primary may be difficult to discern from metastatic disease.
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nCLE Guided Randomized Controlled Trial for Lung Cancer Diagnosis
Jacksonville, Fla.
The purpose of this study is to compare per pass diagnostic yield of different numbers of sequential needle passes (ROSE) and the procedure duration needed to obtain a contributive TBNA sample with ROBOTIC-guided TBNA to that of ROBOTIC-guided nCLE in PPNs.
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Closed for Enrollment
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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
Rochester, Minn.
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.
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A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
Rochester, Minn.
The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.
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Achalasia Patient Reported Outcomes
Rochester, Minn.
The purpose of this study is to gather information and determine if one achalasia procedure at Mayo Clinic Rochester is superior to the other.
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CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Patients
Rochester, Minn.
The purpose of this study is to evaluate whether CAN-2409 + prodrug added to standard of care immune checkpoint inhibitor (ICI) therapy will be safe and improve the outcome for Non-small Cell Lung Cancer (NSCLC) patients that have stable disease or readiographic progression after at least 18 weeks of ICI therapy or that have refractory disease after at least 9 weeks of ICI therapy.
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Clinical Evaluation of ASP Health's Automated ROSE System for Bronchoscopic Applications
Rochester, Minn.
The purpose of this study is to compare cytology slides (bronchoscopically derived fine needle aspiration samples of lymph nodes at the time of rapid intraprocedural on site evaluation) created with the ASP Health's specimen preparation system to slides made by existing conventional methods.
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KM3D Multicenter Cancer Consortium Study: Validation of In Vitro 3D Cell Culture Models for Tumor Drug Sensitivity After Tissue Removal (KM-20-001)
Rochester, Minn.
The purpose of this study is to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.
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Mayo Clinic Foregut Surgery Report Card Questionnaire
Rochester, Minn.
The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing foregut surgery in order to standardize and validate outcome measures.
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Neoadjuvant Soft Tissue Ablation Utilizing Aliya™ Pulsed Electric Fields with Systemic Therapy in
Early-Stage Resectable Non-Small Cell Lung Cancer
(NSCLC) (VIGOR)
Rochester, Minn.
The purpose of this study is to evaluate the pathologic response of soft tissue ablated with Pulsed Electric Fields (PEF) in patients with non-small cell lung cancer (NSCLC) who may be candidates for resection following standard of care (SOC) neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.
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Patient Satisfaction with Televisits for Surgery
Rochester, Minn.
The aim of this study is to identify factors that demonstrate efficiency while maintaining downstream revenue, increase surgical case yield out of clinic, and increase patient and provider satisfaction with telehealth.
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Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay
Rochester, Minn.
The investigators believe that the lessons learned from studies regarding 30-day and 90-day readmission are primarily due to failure of early symptom recognition, and medical error. Through the aid of remote monitoring and early symptom detection, the hypothesis for the current proposal is that interventions can be recommended in an earlier, remote fashion that may result in earlier post-surgical discharge, prevent decompensation, and prevent increased readmissions that have been associated with decreased LOS in other surgical populations.
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PRECIsE – A Prospective Evaluation of the Clinical Utility for the Ion™Endoluminal System (PRECIsE)
Rochester, Minn.
The purpose of this study is to evaluate the clinical utility and early performance of the FDA cleared Ion™ Endoluminal System (“Ion”) for brochoscopically approaching and facilitating the sampling of peripheral pulmonary nodules, between 1-3cm in size, of unknown etiology.
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