Asthma Clinical Trial
Official title:
Neurostimulation for the Relief of Acute Bronchoconstriction
The goal of this study is to validate design for the Resolve™ Stimulator and Proximity Electrode and the associated procedure to quickly and safely place an electrode into the neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm that the electrical signal being delivered via this electrode rapidly counters bronchoconstriction and improves airway flow.
The present study is to evaluate the safety of a new neurostimulator device, the Resolve
Stimulator and Proximity Lead™, which comprises an external electrical signal generator
coupled to temporary electrode that is percutaneously inserted in the neck.
Sponsor believes, based on animal testing data provided as well as consultations with
physicians who regularly treat patients suffering from attacks of acute bronchoconstriction
in ER and inpatient hospital settings, that this device could be used in the skilled care
hospital setting to help rapidly relax the smooth muscle in the airway, relieving a
clinically significant portion of the bronchoconstriction suffered by patients experiencing
moderate to severe asthma attacks, allowing more effective delivery of inhaled medications to
restore the patient to his or her baseline respiration status.
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