Interventional Pulmonology Clinical Trials

The Duke Division of Pulmonary, Allergy, and Critical Care Medicine is actively engaged in clinical research activities to advance our knowledge about the diagnosis and treatment of airway invasion by lung cancer and malignant pleural effusions.

Current Clinical Trials

The following clinical research initiatives are being conducted in our division:

⨀ Valves for severe emphysema:

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: Recruiting
IRB number Pro00103871
ClinicalTrials.gov  
Study Coordinator: Kathleen Coles (919) 668-3812

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

⨀ Chronic Bronchitis:

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
Status: Recruiting
IRB number: Pro00102593
ClinicalTrials.gov : NCT03893370
Study Coordinator: Kathleen Coles (919) 668-3812

⨀ Lung Nodule:

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: Recruiting
IRB Number:  Pro00104802
ClinicalTrials.gov NCT04171492
Study Coordinator: Kathleen Coles (919) 668-3812

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: Recruiting
IRB Number:  Pro00104724
ClinicalTrials.gov:   
Study Coordinator: Lauren Gray (919) 684-7317

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: Recruiting
IRB Number:  Pro00110345
ClinicalTrials.gov  
Study Coordinator: Kathleen Coles (919) 668-3812

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

Principal Investigator: Coral Giovacchini, MD
Status: Recruiting
IRB Number:  Pro00107001
ClinicalTrials.gov:   
Study Coordinator: Lauren Gray (919) 684-7317

This study is comparing which procedure is the best for patients referred for biopsy of a lung nodule meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy comparison: CT-guided Biopsy vs. Navigational Bronchoscopy.

Principal Investigator: Kamran Mahmood, MD
Status: Recruiting
IRB Number:  Pro00107073
ClinicalTrials.gov:  NCT04250194
Study Coordinator: Jessica Shier (919) 684-9139

The purpose of this study is to collect blood samples and medical data to help Nucleix, Inc. in the development of a test that aims to differentiate between individuals at high-risk with and without lung cancer. This test may allow for the early detection of stage I and II lung cancer tumors in patients at high-risk from a simple blood sample.

Principal Investigator: Coral Giovacchini, MD
Status: Recruiting
IRB Number:  Pro00108798
ClinicalTrials.gov:  NCT04968548
Study Coordinator: Lauren Gray (919) 684-7317

⨀ COPD:

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
Status: Recruiting
IRB Number:  Pro00101912
ClinicalTrials.gov:  NCT03639051
Study Coordinator: Jessica Shier (919) 684-9139

⨀ Pleural Effusion:

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: Recruiting
IRB Number:  Pro00074697
ClinicalTrials.gov:   
Study Coordinator: Jessica Shier (919) 684-9139

The primary purpose of this study is to confirm continued safety and performance of Cook Pleural Drainage Sets throughout the expected lifetime of the device.

Principal Investigator:  
Status: Retrospective (data collection)
IRB Number:  Pro00111635
ClinicalTrials.gov  
Study Coordinator: Kathleen Coles (919) 668-3812

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
Status: On Hold
IRB Number:  Pro00107258
ClinicalTrials.gov:  NCT04792970
Study Coordinator: Jessica Shier (919) 684-9139

Historically Relevant Clinical Trials

The purpose of this study is to determine if the rate of spontaneous pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency of pleural drainage and, if so, whether catheter-related complications can be minimized and spare patients the need for long-term management of the Pleurx® catheter.

Principal Investigator: Momen Wahidi, MD, MBA
Sub-Investigator: Scott Shofer, MD, PhD
IRB Number:  
Clinicaltrials.gov NCT00978939

 

This study will assign subjects with chemo-naive advanced non-small cell lung cancer (NSCLC) to chemotherapy using a genomic-based predictor to determine platinum sensitivity. Subjects with squamous cell NSCLC who are sensitive to cisplatin will receive cisplatin/gemcitabine, and if resistant to cisplatin will receive docetaxel/gemcitabine. Subjects with non-squamous cell NSCLC who are sensitive to cisplatin will receive cisplatin/pemetrexed, and if resistant to cisplatin will receive pemetrexed/gemcitabine.

Sub-Investigator: Momen Wahidi, MD, MBA
IRB Number:  
Clinicaltrials.gov NCT00509366

Enroll in a Pulmonary Clinical Trial at Duke

Researchers in our division are investigating a variety of treatments and therapies to respond to lung disease.
Click here  to view a list of current clinical trials for Pulmonary.