Interventional Pulmonology Clinical Trials

The objective of this study is to investigate the differences in quantitative CT chest analysis software provided to aid with patient selection for bronchoscopic lung volume reduction with valves in patients with severe emphysema.

Principal Investigator: Michael Dorry, MD
Status: Retrospective (data collection)
IRB number: Pro00111418
ClinicalTrials.gov: 
Study Coordinator: Jessica Shier  •  (919) 684-9139

The purpose of this registry study is to collect information on the long-term safety and effectiveness of the Spiration Valve System in a real-world setting. This study will look at safety by tracking adverse events (health problems that may or may not be related to the device) and survival.

Principal Investigator: Coral Giovacchini, MD
Status: Open to accrual
IRB number: Pro00103871
ClinicalTrials.gov
Study Coordinator: Jessica Shier  •  (919) 684-9139

This study evaluates if including the Nodify XL2 test results in the decision-making process when planning the management of lung nodules will reduce the number of unnecessary surgical and biopsy procedures.

Principal Investigator: Coral Giovacchini, MD
Status: Closed to accrual
IRB Number: Pro00104802
ClinicalTrials.gov: NCT04171492
Study Coordinator: Jessica Shier  •  (919) 684-9139

This study is evaluating a biopsy tool currently used in usual clinical care, known as a cryoprobe, on its ability to acquire more tissue during a bronchoscopy procedure for molecular analysis. 

Principal Investigator:  Cristina Salmon, MD
Status: Open to accrual
IRB Number: Pro00116977
ClinicalTrials.gov:     
Study Coordinator: Jessica Shier  •  (919) 684-9139
 

The purpose of this study is to develop and evaluate a cancer biomarker test as an aid in the diagnosis and risk assessment of lung cancer. A cancer biomarker refers to a substance found in blood or body fluid that indicates the presence of cancer in the body.

Principal Investigator: Coral Giovacchini, MD
Status: Closed to accrual
IRB Number: Pro00104724
ClinicalTrials.gov: 
Study Coordinator: Jessica Shier  •  (919) 684-9139

This study is evaluating the usefulness of a genomic test, the Percepta Nasal Swab, in determining the risk of lung cancer when a lung nodule is detected by imaging performed as part of lung cancer screening or incidentally during a medical workup.

Principal Investigator: Coral Giovacchini, MD
Status: Closed to accrual
IRB Number: Pro00104724
ClinicalTrials.gov: 
Study Coordinator: Lauren Gray  •  (919) 684-7317

This study evaluates the sensitivity of a novel sequencing technique (maximum depth sequencing (MDS)) for detecting KRAS mutations in blood specimens as compared with commercially available Next Gen Sequencing (NGS) liquid biopsy. 

Principal Investigator: Scott Shofer, MD
Status: Open to accrual
IRB Number: Pro00118469
ClinicalTrials.gov:     
Study Coordinator: Lauren Gray  •  (919) 684-7317

This study is a longitudinal multi-omic biomarker profiling study of patients with NSCLC. The study collects serial blood samples before, during, and after treatment and/or tissue collection from routine care procedures to determine if the tumor genetic makeup has changed over time. 

Principal Investigator: Kamran Mahmood, MD
Status: Open to accrual
IRB Number: Pro00110875
ClinicalTrials.gov:     
Study Coordinator: Lauren Gray  •  (919) 684-7317
 

This study is assessing if blood and fluid from around the lungs can be used to perform DNA analysis to diagnose the cause of pleural effusion and determine whether it is cancerous, and to compare this to samples (biopsies) of the lung cancer that will be collected during a bronchoscopy procedure.

Principal Investigator: Kamran Mahmood, MD
Status: Closed to accrual
IRB Number: Pro00074697
ClinicalTrials.gov: 
Study Coordinator: Jessica Shier  •  (919) 684-9139

The objective of this study is to assess the use and performance of the Galvanize PEF technology in a real-world setting. Patients who have undergone the Galvanize PEF as standard of care treatment will be included in this registry study. 

Principal Investigator: Kamran Mahmood, MD
Status: Open to accrual for Retrospective and Prospective (data collection)
IRB number: Pro00117753
ClinicalTrials.gov:     
Study Coordinator: Jessica Shier  •  (919) 684-9139

The primary purpose of this study is evaluating if Targeted Lung Denervation (TLD) in addition to optimal medical care (daily breathing medications prescribed by your doctor) is better at reducing a moderate or severe COPD exacerbation than optimal medical care alone. To test this, participants will be randomly assigned to receive one of two different procedures, either TLD in addition to optional medical care (Active Study Procedure) or optimal medical care (Sham Control).

Principal Investigator: Kamran Mahmood, MD
IRB Number: Pro00101912
ClinicalTrials.gov: NCT03639051
Study Coordinator: Jessica Shier  •  (919) 684-9139

The purpose of this study is to determine the safety and effectiveness of a new device, RejuvenAir System, developed for patients with chronic bronchitis. The RejuvenAir System being examined in this study is an investigational device, which delivers liquid nitrogen through a catheter to instantly flash freeze the lining of the airways (also called metered spray cryotherapy) to regrow healthy tissue. To test this, participants will be randomly assigned to receive one of two different procedures, either cryotherapy in addition to optimal medical care (Active Study Procedure) or optimal medical care (Sham Control).

Principal Investigator: Kamran Mahmood, MD
IRB number:  Pro00102593
ClinicalTrials.gov : NCT03893370
Study Coordinator: Jessica Shier  •  (919) 684-9139

The purpose of this study is to compare the experiences of subjects who drain malignant (cancerous) pleural effusions (fluid) from around their lung(s) in a more frequent manner using a talc instilled via tunneled pleural catheter combined with daily drainage and those subjects who drain this fluid in a daily standard manner

Principal Investigator: Scott Shofer, MD, PhD
IRB Number:  Pro00107258
ClinicalTrials.gov: NCT04792970
Study Coordinator: Jessica Shier  •  (919) 684-9139