A Pilot Study to Assess the Effects of Simeox 200 Airway Clearance Device in Bronchiectasis Patients with Chronic Mucus Hypersecretion

Date Added
October 14th, 2025
PRO Number
Pro00147345
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis, Lung
Summary

This will be a study in the home care setting to further validate the concept of Simeox 200 in a cohort of patients with bronchiectasis and overproduction of mucous as an alternative to other methods of ACT(airway clearance techniques). Bronchiectasis is a chronic lung disease where airways become permanently damaged, widened, and lose their ability to clear mucus, leading to a buildup of bacteria, recurrent infections, and symptoms like a daily cough, thick, discolored phlegm, shortness of breath, and fatigue. The device is a 510(k) FDA cleared device that works using by air and vibration to help clear mucous from the lungs. There are 4 visits and an at home usage period. The study will be running approximately a year or until the cohort is filled. The data from this study will be used to power a future randomized controlled pivotal clinical study comparing Simeox 200 against other ACTs such as High Frequency Chest Wall Oscillation (HFCWO).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Lung Cancer Screening, Lung Nodule, and Lung Cancer Biorepository

Date Added
April 24th, 2025
PRO Number
Pro00143404
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Lung
Summary

This study will enroll patients and collect blood samples from those who are either in lung cancer screening, have a lung nodule that is suspicious for malignancy, a newly diagnosed cancer, or healthy control subjects. These samples that are being collected and banked will be used for future development of blood tests to detect lung cancer in future patients at the earliest stages.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Lung Cancer Screening, Lung Nodule, and Lung Cancer Biorepository

Date Added
April 24th, 2025
PRO Number
Pro00143404
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Lung
Summary

This study will enroll patients and collect blood samples from those who are either in lung cancer screening, have a lung nodule that is suspicious for malignancy, a newly diagnosed cancer, or healthy control subjects. These samples that are being collected and banked will be used for future development of blood tests to detect lung cancer in future patients at the earliest stages.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Lung Cancer Screening, Lung Nodule, and Lung Cancer Biorepository

Date Added
April 24th, 2025
PRO Number
Pro00143404
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Lung
Summary

This study will enroll patients and collect blood samples from those who are either in lung cancer screening, have a lung nodule that is suspicious for malignancy, a newly diagnosed cancer, or healthy control subjects. These samples that are being collected and banked will be used for future development of blood tests to detect lung cancer in future patients at the earliest stages.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Lung Cancer Screening, Lung Nodule, and Lung Cancer Biorepository

Date Added
April 24th, 2025
PRO Number
Pro00143404
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Lung
Summary

This study will enroll patients and collect blood samples from those who are either in lung cancer screening, have a lung nodule that is suspicious for malignancy, a newly diagnosed cancer, or healthy control subjects. These samples that are being collected and banked will be used for future development of blood tests to detect lung cancer in future patients at the earliest stages.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Sleep and Activity Habits of Inpatients with Chest Tubes: A Pilot Observational Trial

Date Added
April 9th, 2025
PRO Number
Pro00140546
Researcher
Christopher Gilbert

List of Studies

Keywords
Lung, Pulmonary
Summary

This is a non-invasive, observational study aiming to collect data on the impact chest tubes have on inpatients during their hospitalizations. Sleep and activity patterns, as well as select vital signs will be tracked using an MUSC-owned Apple Watch, which subjects will wear, and an MUSC-owned iPhone, for up to seven days during admission to the hospital. Each day, a study coordinator will visit subjects to collect a brief sleep survey. Participation may last up to 7 days while subjects are admitted and have a chest tube in place. Upon completion of the study, a study coordinator will collect the Apple Watch and iPhone for data analysis.

This pilot data will provide initial information on the feasibility of collecting and performing a larger study on the inpatient mobility, activity, and sleep.

Institution
MUSC
Recruitment Contact
Randal Neff
8437924557
Neffr@musc.edu

A Multicenter Randomized Trial of EBUS-TBNA versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing: FROSTBITE-3

Date Added
March 18th, 2025
PRO Number
Pro00140380
Researcher
Christopher Gilbert

List of Studies

Keywords
Cancer, Lung, Pulmonary
Summary

This study is for patients scheduled for a bronchoscopy, a procedure that allows doctors to examine lungs and airways for evaluation of suspicious lung nodules. Those who give consent to participate in this study will be randomized into one of two lung biopsy sampling method groups based on the Rapid On Site Evaluation of the initial sample obtained by the doctor performing the bronchoscopy as part of the standard of care procedure for the patient. the potential groups the subject will be randomized into are: Cryoprobe or transbronchial biopsy needle. These devices are used with a bronchoscope to obtain lung tissue biopsy samples and are being evaluated to determine which is better for confirming a diagnosis. All procedures will be done via standard of care and screening will be accomplished via medical chart review. 7 days following the procedure, a member of the study team will check the subjects medical chart to assess whether any adverse events have occurred.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

CRISPR detection of circulating cell-free Mycobacterium avium complex (MAC) DNA for rapid diagnosis and monitoring of MAC pulmonary disease

Date Added
March 5th, 2025
PRO Number
Pro00140587
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

The study includes both a retrospective cross-sectional and prospective longitudinal cohort study design. Demographic and clinical data will be obtained through medical record review. 3-4 blood draws will be collected over the course of the study. If participants were also in the MAC2v3 or NTM PRO Cohort study, data collected for that study will be used in this study. About 450 subjects are expected to participate in this study at 7 research sites in the United States. Participation in this study is expected to last up to 12 months. During that time, participants will have about 3-4 study visits.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

RELIANCE: A phase 1, randomized, double-blinded, placebo-controlled, trial evaluating the long-term safety and tolerability of Imatinib for the treatment of Lymphangioleiomyomatosis (LAMP-2 Trial)

Date Added
July 30th, 2024
PRO Number
Pro00136539
Researcher
Charlie Strange

List of Studies


Keywords
Kidney, Lung, Pulmonary, Rare Diseases, Women's Health
Summary

The purpose of this medical research study is to evaluate the safety and effectiveness of a new medication called imatinib mesylate in the treatment of Lymphangioleiomyomatosis (LAM). LAM is a rare disease in which abnormal cells (called LAM cells) grow out of control. Over time, LAM cells destroy healthy lung tissue and cause respiratory disease or failure.

Many patients with LAM are currently treated with a medication called sirolimus (rapamycin). Sirolimus slows the growth of LAM cells.

Imatinib mesylate (hereafter called imatinib) is approved by the Food and Drug Administration (FDA) for the treatment of some cancers that share common pathways with LAM cells. Laboratory studies suggest that imatinib could completely block the growth of LAM cells through initiation of targeted cell death.

An important purpose of this research is to determine the safety of imatinib in people with LAM. This study will also evaluate the short-term effectiveness of imatinib. Participants will be randomized to receiving imatinib (study medication) or placebo (no treatment) for the 180 day duration of participation. The study is being conducted at the Medical University of South Carolina and at Columbia University in New York (CUMC). Each site will enroll 10 participants.

Institution
MUSC
Recruitment Contact
Mary Hayden
(843) 792-8438
blantonm@musc.edu

Patient reported outcomes in patients with nontuberculous mycobacterial pulmonary disease

Date Added
July 29th, 2024
PRO Number
Pro00133747
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

Nontuberculous mycobacteria (NTM) cause a chronic pulmonary infection associated with cough, fatigue, and shortness of breath. Our primary objectives are to better understand the trajectory of patient-reported outcomes (PROs), e.g.
respiratory symptoms and health-related quality of life (HRQoL), across the entire disease course and measure toxicity and tolerability using patient-reported symptomatic adverse events in treated patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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