Cystic Fibrosis – Clinical Phase IV Trial Complete – Results Pending

Med Systems is sponsoring a Phase IV clinical study to measure the effectiveness of the Electro Flo 5000 Airway Clearance System for people who have been diagnosed with cystic fibrosis. The goal of the study is to provide health insurers and Medicare with comprehensive information regarding the system’s performance. The study is designed to measure the efficacy of the system, which includes the FDA510K (K031876) device under current indications. The study will last 23 days and involve using the system for lung clearance and recording the results in a digital journal. The study should take about 10 minutes per day to record measured results in the morning after waking. You will also be asked to use a spirometer and a digital pulse oximeter to evaluate your lung function after using the Electro Flo 5000 Airway Clearance System. Participants will be offered reimbursement amount of $7.00 a day, for submitted daily data, for a total of 21 days.

Interested participants must be:

  • Between the ages of 18-55 years of age
  • Diagnosed with Cystic Fibrosis
  • Prescribed chest physical therapy for airway clearance
  • Able to perform self-treatment- having manual dexterity
  • Residing in the United States

 

The Beneficial Cough

Coughing to clear the lungs of congestion is fundamental for patients with obstructive lung disorders, neuromuscular diseases and restrictive airway disorders. Such coughs are associated with COPD, bronchitis, viral and bacterial types of pneumonia, cystic fibrosis, occupational lung disease and many other respiratory conditions. If left untreated, the buildup of mucus can lead to serious infections. So what is coughing and how can the hand-held Electro Flo 5000 Airway Clearance System ensure that patients get the specific relief they seek?

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Bronchiectasis

Bronchiectasis is a disease that causes the airways or bronchial tubes of the lungs to widen and become flabby.  It is caused by infections or other conditions that destroy the smooth muscles surrounding the bronchial tubes and prevents the airways from clearing mucus. The goal of treatment for bronchiectasis is to control the secretions and prevent infections.

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Treatment For Neuromuscular Disease

Neuromuscular diseases are rare conditions affecting the nerves that control voluntary or involuntary muscles. This group of diseases may be genetic and present at birth or acquired later in life.  Most treatments for neuromuscular disease are aimed at minimizing the symptoms and improving a person’s quality of life rather than seeking a cure. Neuromuscular disease includes among others, MUSCULAR DYSTROPHY, MYASTHENIA GRAVIS, and AMYOTROPHIC LATERAL SCLEROSIS also known as ALS or Lou Gehrig’s disease. Neuromuscular disease includes a broad spectrum of illnesses that may require treatment for relief in breathing.

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Respiratory Care

RESPIRATORY CARE Choices for Cystic Fibrosis Patients and Respiratory Therapists

Cystic Fibrosis is characterized by thickened mucus, chronic infection and inflammation of the airways.  Patients with this disease engage in daily respiratory therapy. Effective respiratory care can vary widely, depending on the needs of the individual.

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Chest Percussion

Chest Percussion is used to treat individuals with cystic fibrosis (CF) and other lung diseases such as bronchitis, pneumonia, or chronic obstructive pulmonary disease (COPD) who are in need of airway clearance. Among CF patients, chest percussion helps to break up thick secretions created by the disease that can hinder breathing and lead to respiratory infections.

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Cystic Fibrosis Treatment.

Cystic fibrosis (CF) is an inherited disease with a wide range of symptoms that affect everything from how well the lungs, digestive system, and sweat glands function, to fertility. The name “cystic fibrosis” comes from the fibrous scaring that develops in the pancreas. CF causes thick mucus to be secreted by the lungs and pancreas that blocks passageways, making it difficult to clear pathogens that lead to chronic pulmonary infections and inflammation.

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